For delayed applicability of subsection (z) of this section as added by section 3601(a) of Pub. L. 117–328, see Effective Date of 2022 Amendment note below.
Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (k)(3)(C)(i)(I), (4)(G)(i)(I), is section 264(c) of Pub. L. 104–191, which is set out as a note under section 1320d–2 of Title 42, The Public Health and Welfare.
The General Schedule, referred to in subsec. (n)(5), is set out under section 5332 of Title 5, Government Organization and Employees.
Section 101(c) of the Food and Drug Administration Amendments Act of 2007, referred to in subsec. (o)(3)(E)(i), is section 101(c) of Pub. L. 110–85, which is set out as a note under section 379g of this title.
The Food and Drug Administration Modernization Act of 1997, referred to in subsec. (v)(1)(A), (2)(A), (4), is Pub. L. 105–115,
The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in subsec. (v)(4), is Pub. L. 98–417,
The Controlled Substances Act, referred to in subsec. (x)(1), is title II of Pub. L. 91–513,
In subsec. (k)(4)(H), “section 132 of title 41” substituted for “section 4(5) of the Federal Procurement Policy Act” on authority of Pub. L. 111–350, § 6(c),
2022—Subsec. (i)(1)(A). Pub. L. 117–328, § 3209(a)(1)(A), substituted “nonclinical tests” for “preclinical tests (including tests on animals)”.
Subsec. (i)(2)(B). Pub. L. 117–328, § 3209(a)(1)(B), substituted “nonclinical tests” for “animal”.
Subsec. (j)(7)(A)(v). Pub. L. 117–328, § 3222, added cl. (v).
Subsec. (j)(10)(A)(i) to (iii). Pub. L. 117–328, § 3224, added cls. (i) to (iii) and struck out former cls. (i) to (iii) which read as follows:
“(i) the application is otherwise eligible for approval under this subsection but for expiration of patent, an exclusivity period, or of a delay in approval described in paragraph (5)(B)(iii), and a revision to the labeling of the listed drug has been approved by the Secretary within 60 days of such expiration;
“(ii) the labeling revision described under clause (i) does not include a change to the ‘Warnings’ section of the labeling;
“(iii) the sponsor of the application under this subsection agrees to submit revised labeling of the drug that is the subject of such application not later than 60 days after the notification of any changes to such labeling required by the Secretary; and”.
Subsec. (u)(1)(A)(ii)(II). Pub. L. 117–328, § 3105(1), inserted “(other than bioavailability studies)” after “any clinical investigations”.
Subsec. (u)(4). Pub. L. 117–328, § 3105(2), substituted “
Pub. L. 117–229 substituted “
Pub. L. 117–180 substituted “December 17” for “October 1”.
Subsec. (z). Pub. L. 117–328, § 3601(a), added subsec. (z) relating to diversity action plan for clinical studies.
Pub. L. 117–328, § 3209(a)(2), added subsec. (z) defining nonclinical test.
2021—Subsec. (b)(1). Pub. L. 116–290, § 2(a)(1), amended par. (1) generally. Prior to amendment, par. (1) related to requirements for filing an application with respect to any drug subject to the provisions of subsec. (a).
Subsec. (c)(2). Pub. L. 116–290, § 2(b)(1), inserted at beginning “Not later than 30 days after the date of approval of an application submitted under subsection (b), the holder of the approved application shall file with the Secretary the patent number and the expiration date of any patent described in subsection (b)(1)(A)(viii), except that a patent that is identified as claiming a method of using such drug shall be filed only if the patent claims a method of use approved in the application. If a patent described in subsection (b)(1)(A)(viii) is issued after the date of approval of an application submitted under subsection (b), the holder of the approved application shall, not later than 30 days after the date of issuance of the patent, file the patent number and the expiration date of the patent, except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application.”; substituted “described in subsection (b)(1)(A)(viii).” for “which claims the drug for which the application was submitted or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.”; inserted “of the type for which information is required to be submitted in subsection (b)(1)(A)(viii)” after “could not file patent information under subsection (b) because no patent”; and inserted at end “Patent information that is not the type of patent information required by subsection (b)(1)(A)(viii) shall not be submitted under this paragraph.”
Subsec. (c)(3)(E). Pub. L. 117–9, § 1(a)(1)(A), substituted “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))” for “active ingredient (including any ester or salt of the active ingredient)” wherever appearing.
Pub. L. 116–290, § 2(g)(1), substituted “subsection (b)(1)(A)(i)” for “clause (A) of subsection (b)(1)” wherever appearing.
Subsec. (c)(3)(E)(i). Pub. L. 117–9, § 1(b)(1)(A), struck out cl. (i) which read as follows: “If an application (other than an abbreviated new drug application) submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), was approved during the period beginning
Subsec. (j)(2)(A)(vi). Pub. L. 116–290, § 2(g)(2), substituted “clauses (ii) through (vi) of subsection (b)(1)(A)” for “clauses (B) through (F) of subsection (b)(1)”.
Subsec. (j)(5)(F). Pub. L. 117–9, § 1(a)(1)(B), substituted “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))” for “active ingredient (including any ester or salt of the active ingredient)” wherever appearing.
Subsec. (j)(5)(F)(i). Pub. L. 117–9, § 1(b)(1)(B), struck out cl. (i) which read as follows: “If an application (other than an abbreviated new drug application) submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), was approved during the period beginning
Subsec. (j)(7)(A)(iii). Pub. L. 116–290, § 2(b)(2), struck out “(b) or” before “(c)”.
Subsec. (j)(7)(A)(iv). Pub. L. 116–290, § 2(c), added cl. (iv).
Subsec. (j)(7)(D). Pub. L. 116–290, § 2(d)(1), added subpar. (D).
Subsec. (l)(2)(A)(i). Pub. L. 117–9, § 1(a)(1)(C)(i), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: “not later than 30 days after the date of approval of such application for a drug no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under this section or section 262 of title 42; and”.
Subsec. (l)(2)(A)(ii). Pub. L. 117–9, § 1(a)(1)(C)(ii), inserted “or biological product” before period at end.
Subsec. (s). Pub. L. 117–9, § 1(a)(1)(D), amended subsec. (s) generally. Prior to amendment, text read as follows: “Prior to the approval of a drug no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under this section or section 262 of title 42, the Secretary shall—
“(1) refer such drug to a Food and Drug Administration advisory committee for review at a meeting of such advisory committee; or
“(2) if the Secretary does not refer such a drug to a Food and Drug Administration advisory committee prior to the approval of the drug, provide in the action letter on the application for the drug a summary of the reasons why the Secretary did not refer the drug to an advisory committee prior to approval.”
Subsec. (u)(1). Pub. L. 117–9, § 1(a)(1)(E), in introductory provisions, substituted “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))” for “active ingredient (including any ester or salt of the active ingredient)” and “same active moiety” for “same active ingredient”.
2018—Subsec. (o)(4)(A). Pub. L. 115–271, § 3041(b)(1), substituted “safety or new effectiveness information” for “safety information” in heading and “If the Secretary becomes aware of new information, including any new safety information or information related to reduced effectiveness, that the Secretary determines should be included in the labeling of the drug” for “If the Secretary becomes aware of new safety information that the Secretary believes should be included in the labeling of the drug” in text. Amendment to heading was executed to reflect the probable intent of Congress, notwithstanding error in text directed to be stricken.
Subsec. (o)(4)(B)(i). Pub. L. 115–271, § 3041(b)(2), inserted “, or new effectiveness information” after “adverse reactions”.
Subsec. (o)(4)(C). Pub. L. 115–271, § 3041(b)(3), substituted “safety or new effectiveness information” for “safety information”.
Subsec. (o)(4)(E). Pub. L. 115–271, § 3041(b)(4), substituted “safety or new effectiveness information” for “safety information”.
2017—Subsec. (j)(5)(B)(v). Pub. L. 115–52, § 808(1), added cl. (v).
Subsec. (j)(5)(D)(iv). Pub. L. 115–52, § 808(2), added cl. (iv).
Subsec. (j)(11), (12). Pub. L. 115–52, § 801, added pars. (11) and (12).
Subsec. (j)(13). Pub. L. 115–52, § 802, added par. (13).
Subsec. (k)(5). Pub. L. 115–52, § 901(a), made technical amendments to directory language of Pub. L. 114–255, § 3075(a). See 2016 Amendment notes below.
Subsec. (u)(4). Pub. L. 115–52, § 601, substituted “2022” for “2017”.
Subsec. (y). Pub. L. 115–52, § 706(b), added subsec. (y).
2016—Subsec. (c)(5). Pub. L. 114–255, § 3031(a), added par. (5).
Subsec. (d). Pub. L. 114–255, § 3101(a)(2)(B)(i), substituted “marketing approval” for “premarket approval” in last sentence.
Subsec. (i)(4). Pub. L. 114–255, § 3024(b), substituted “except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings” for “except where it is not feasible or it is contrary to the best interests of such human beings”.
Subsec. (k)(5)(A). Pub. L. 114–255, § 3075(a)(1), as amended by Pub. L. 115–52, § 901(a)(1), substituted “screenings” for “, bi-weekly screening”.
Pub. L. 114–255, § 3102(1)(A), inserted “and” after the semicolon.
Subsec. (k)(5)(B). Pub. L. 114–255, § 3075(a)(2), as amended by Pub. L. 115–52, § 901(a), substituted “; and” for period at end.
Pub. L. 114–255, § 3102(1)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: “report to Congress not later than 2 year after
Subsec. (k)(5)(C). Pub. L. 114–255, § 3075(a)(3), as amended by Pub. L. 115–52, § 901(a)(1), added subpar. (C).
Pub. L. 114–255, § 3102(1)(C), redesignated subpar. (C) as (B).
Subsec. (q)(5)(A). Pub. L. 114–255, § 3101(a)(2)(B)(ii), substituted “subsection (b)(2) or (j) of this section or section 262(k) of title 42” for “subsection (b)(2) or (j) of the Act or 262(k) of title 42”.
Subsec. (r)(2)(D). Pub. L. 114–255, § 3075(b), substituted “and making publicly available on the Internet website established under paragraph (1) best practices for drug safety surveillance activities for drugs approved under this section or section 262 of title 42” for “, by 18 months after approval of a drug or after use of the drug by 10,000 individuals, whichever is later, a summary analysis of the adverse drug reaction reports received for the drug, including identification of any new risks not previously identified, potential new risks, or known risks reported in unusual number;”.
2015—Subsec. (x). Pub. L. 114–89 added subsec. (x).
2013—Subsec. (b)(5)(B). Pub. L. 113–5 substituted “size—” for “size of clinical trials intended to form the primary basis of an effectiveness claim or, with respect to an applicant for approval of a biological product under section 262(k) of title 42, any necessary clinical study or studies.”, added cls. (i) and (ii), and designated last two sentences as concluding provisions.
2012—Subsec. (d). Pub. L. 112–144, § 905, inserted at end “The Secretary shall implement a structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decisionmaking, and the communication of the benefits and risks of new drugs. Nothing in the preceding sentence shall alter the criteria for evaluating an application for premarket approval of a drug.”
Subsec. (q)(1)(A). Pub. L. 112–144, § 1135(1)(A), substituted “subsection (b)(2) or (j) of this section or section 262(k) of title 42” for “subsection (b)(2) or (j)” in introductory provisions.
Subsec. (q)(1)(F). Pub. L. 112–144, § 1135(1)(B), substituted “150 days” for “180 days” in introductory provisions.
Subsec. (q)(2)(A). Pub. L. 112–144, § 1135(2)(A), substituted “150” for “180” in heading.
Subsec. (q)(2)(A)(i). Pub. L. 112–144, § 1135(2)(B), substituted “150-day” for “180-day”.
Subsec. (q)(4). Pub. L. 112–144, § 1135(3), designated existing provisions as subpar. (A), redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A), and added subpar. (B).
Subsec. (q)(5)(A). Pub. L. 112–144, § 1135(4), substituted “subsection (b)(2) or (j) of the Act or 262(k) of title 42” for “subsection (b)(2) or (j)”.
Subsec. (u)(1)(A)(ii)(II). Pub. L. 112–144, § 1101(b), inserted “clinical” after “any”.
Subsec. (u)(4). Pub. L. 112–144, § 1101(a), substituted “2017” for “2012”.
Subsec. (w). Pub. L. 112–144, § 1134(a), added subsec. (w).
2010—Subsec. (b)(5)(B). Pub. L. 111–148, § 7002(d)(1), inserted “or, with respect to an applicant for approval of a biological product under section 262(k) of title 42, any necessary clinical study or studies” before period at end of first sentence.
Subsec. (j)(10). Pub. L. 111–148, § 10609, added par. (10).
2009—Subsec. (n)(2). Pub. L. 111–31 made technical amendment to reference in original act which appears in text as reference to section 394 of this title.
2008—Subsec. (q)(1)(A). Pub. L. 110–316, § 301, inserted concluding provisions.
Subsec. (v). Pub. L. 110–379 added subsec. (v).
2007—Subsec. (b)(6). Pub. L. 110–85, § 801(b)(3)(B), added par. (6).
Subsec. (e). Pub. L. 110–85, § 903, inserted at end “The Secretary may withdraw the approval of an application submitted under this section, or suspend the approval of such an application, as provided under this subsection, without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation strategy for the drug under section 355–1(g)(2)(D) of this title.”
Subsec. (i)(4). Pub. L. 110–85, § 801(b)(3)(A), inserted at end “The Secretary shall update such regulations to require inclusion in the informed consent documents and process a statement that clinical trial information for such clinical investigation has been or will be submitted for inclusion in the registry data bank pursuant to subsection (j) of section 282 of title 42.”
Subsec. (k)(3), (4). Pub. L. 110–85, § 905(a), added pars. (3) and (4).
Subsec. (k)(5). Pub. L. 110–85, § 921, added par. (5).
Subsec. (l). Pub. L. 110–85, § 916, designated existing provisions as par. (1), redesignated former pars. (1) to (5) as subpars. (A) to (E), respectively, of par. (1), and added par. (2).
Subsec. (n)(4) to (8). Pub. L. 110–85, § 701(b), redesignated pars. (5) to (8) as (4) to (7), respectively, and struck out former par. (4) which read as follows: “Each member of a panel shall publicly disclose all conflicts of interest that member may have with the work to be undertaken by the panel. No member of a panel may vote on any matter where the member or the immediate family of such member could gain financially from the advice given to the Secretary. The Secretary may grant a waiver of any conflict of interest requirement upon public disclosure of such conflict of interest if such waiver is necessary to afford the panel essential expertise, except that the Secretary may not grant a waiver for a member of a panel when the member’s own scientific work is involved.”
Subsecs. (o), (p). Pub. L. 110–85, § 901(a), added subsecs. (o) and (p).
Subsec. (q). Pub. L. 110–85, § 914(a), added subsec. (q).
Subsec. (r). Pub. L. 110–85, § 915, added subsec. (r).
Subsec. (s). Pub. L. 110–85, § 918, added subsec. (s).
Subsec. (t). Pub. L. 110–85, § 920, added subsec. (t).
Subsec. (u). Pub. L. 110–85, § 1113, added subsec. (u).
2003—Subsec. (b)(1). Pub. L. 108–155, in second sentence, substituted “(F)” for “and (F)” and inserted “, and (G) any assessments required under section 355c of this title” before period at end.
Subsec. (b)(3). Pub. L. 108–173, § 1101(b)(1)(A), added par. (3) and struck out former par. (3) which, in subpar. (A), required an applicant making a certification under par. (2)(A)(iv) to include statement that applicant will give notice to each owner of the patent which is the subject of the certification and to the holder of the approved application, in subpar. (B), directed that notice state that an application has been submitted and include a detailed statement of the applicant’s opinion that the patent is not valid or will not be infringed, and, in subpar. (C), provided that if an application is amended, notice shall be given when the amended application is submitted.
Subsec. (b)(4), (5). Pub. L. 108–173, § 1101(b)(1)(B), added par. (4) and redesignated former par. (4) as (5).
Subsec. (c)(3). Pub. L. 108–173, § 1101(b)(2)(A), substituted “by applying the following to each certification made under subsection (b)(2)(A)” for “under the following” in introductory provisions.
Subsec. (c)(3)(C). Pub. L. 108–173, § 1101(b)(2)(B)(iii), which directed the substitution of “subsection (b)(3)” for “paragraph (3)(B)” in third sentence, could not be executed because such words do not appear. See note below.
Pub. L. 108–173, § 1101(b)(2)(B)(ii)(VI), in concluding provisions, struck out “Until the expiration of forty-five days from the date the notice made under paragraph (3)(B) is received, no action may be brought under section 2201 of title 28 for a declaratory judgment with respect to the patent. Any action brought under such section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business.” after “expediting the action.”
Pub. L. 108–173, § 1101(b)(2)(B)(i), (ii)(I), in first sentence of introductory provisions, substituted “unless, before the expiration of 45 days after the date on which the notice described in subsection (b)(3) is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under paragraph (2) or subsection (b)(1) before the date on which the application (excluding an amendment or supplement to the application) was submitted” for “unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under paragraph (3)(B) is received” and, in second sentence of introductory provisions, substituted “subsection (b)(3)” for “paragraph (3)(B)”.
Subsec. (c)(3)(C)(i). Pub. L. 108–173, § 1101(b)(2)(B)(ii)(II), added cl. (i) and struck out former cl. (i) which read as follows: “if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval may be made effective on the date of the court decision,”.
Subsec. (c)(3)(C)(ii). Pub. L. 108–173, § 1101(b)(2)(B)(ii)(III), added cl. (ii) and struck out former cl. (ii) which read as follows: “if before the expiration of such period the court decides that such patent has been infringed, the approval may be made effective on such date as the court orders under section 271(e)(4)(A) of title 35, or”.
Subsec. (c)(3)(C)(iii). Pub. L. 108–173, § 1101(b)(2)(B)(ii)(IV), substituted “as provided in clause (i); or” for “on the date of such court decision.”
Subsec. (c)(3)(C)(iv). Pub. L. 108–173, § 1101(b)(2)(B)(ii)(V), added cl. (iv).
Subsec. (c)(3)(D), (E). Pub. L. 108–173, § 1101(b)(2)(C), (D), added subpar. (D) and redesignated former subpar. (D) as (E).
Subsec. (j)(2)(B). Pub. L. 108–173, § 1101(a)(1)(A), added subpar. (B) and struck out former subpar. (B) which, in cl. (i), required that an applicant making a certification under subpar. (A)(vii)(IV) include in the application a statement that notice would be given to each owner of the patent and the holder of the approved application, in cl. (ii), required that notice would state that an application had been submitted and that it would include a detailed statement of the basis of the applicant’s opinion, and, in cl. (iii), directed that notice of an amended application be given when the amended application had been submitted.
Subsec. (j)(2)(D). Pub. L. 108–173, § 1101(a)(1)(B), added subpar. (D).
Subsec. (j)(5)(B). Pub. L. 108–173, § 1101(a)(2)(A)(i), substituted “by applying the following to each certification made under paragraph (2)(A)(vii)” for “under the following” in introductory provisions.
Subsec. (j)(5)(B)(iii). Pub. L. 108–173, § 1101(a)(2)(A)(ii)(II)(ee), which directed amendment of the second sentence of subsec. (j)(5)(B)(iii) by striking “Until the expiration” and all that follows in the matter after and below subclause (IV), was executed by striking “Until the expiration of forty-five days from the date the notice made under paragraph (2)(B)(i) is received, no action may be brought under section 2201 of title 28, for a declaratory judgment with respect to the patent. Any action brought under section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business.” after “expediting the action.” in concluding provisions, to reflect the probable intent of Congress.
Pub. L. 108–173, § 1101(a)(2)(A)(ii)(I), in introductory provisions, substituted “unless, before the expiration of 45 days after the date on which the notice described in paragraph (2)(B) is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under subsection (b)(1) or (c)(2) before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted” for “unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under paragraph (2)(B)(i) is received”.
Subsec. (j)(5)(B)(iii)(I). Pub. L. 108–173, § 1101(a)(2)(A)(ii)(II)(aa), added subcl. (I) and struck out former subcl. (I) which read as follows: “if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of the court decision,”.
Subsec. (j)(5)(B)(iii)(II). Pub. L. 108–173, § 1101(a)(2)(A)(ii)(II)(bb), added subcl. (II) and struck out former subcl. (II) which read as follows: “if before the expiration of such period the court decides that such patent has been infringed, the approval shall be made effective on such date as the court orders under section 271(e)(4)(A) of title 35, or”.
Subsec. (j)(5)(B)(iii)(III). Pub. L. 108–173, § 1101(a)(2)(A)(ii)(II)(cc), substituted “as provided in subclause (I); or” for “on the date of such court decision.”
Subsec. (j)(5)(B)(iii)(IV). Pub. L. 108–173, § 1101(a)(2)(A)(ii)(II)(dd), added subcl. (IV).
Subsec. (j)(5)(B)(iv). Pub. L. 108–173, § 1102(a)(1), added cl. (iv) and struck out former cl. (iv) which read as follows: “If the application contains a certification described in subclause (IV) of paragraph (2)(A)(vii) and is for a drug for which a previous application has been submitted under this subsection continuing such a certification, the application shall be made effective not earlier than one hundred and eighty days after—
“(I) the date the Secretary receives notice from the applicant under the previous application of the first commercial marketing of the drug under the previous application, or
“(II) the date of a decision of a court in an action described in clause (iii) holding the patent which is the subject of the certification to be invalid or not infringed,
whichever is earlier.”
Subsec. (j)(5)(C). Pub. L. 108–173, § 1101(a)(2)(B), (C), added subpar. (C). Former subpar. (C) redesignated (E).
Subsec. (j)(5)(D). Pub. L. 108–173, § 1102(a)(2), added subpar. (D).
Pub. L. 108–173, § 1101(a)(2)(B), redesignated subpar. (D) as (F).
Subsec. (j)(5)(E), (F). Pub. L. 108–173, § 1101(a)(2)(B), redesignated subpars. (C) and (D) as (E) and (F), respectively.
Subsec. (j)(8)(A). Pub. L. 108–173, § 1103(a)(1), added subpar. (A) and struck out former subpar. (A) which read as follows: “The term ‘bioavailability’ means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug action.”
Subsec. (j)(8)(C). Pub. L. 108–173, § 1103(a)(2), added subpar. (C).
2002—Subsec. (i)(1)(D). Pub. L. 107–109 added subpar. (D).
1999—Subsec. (m). Pub. L. 106–113 substituted “United States Patent and Trademark Office” for “Patent and Trademark Office of the Department of Commerce”.
1997—Subsec. (b)(1). Pub. L. 105–115, § 115(b), inserted at end “The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by clause (A).”
Subsec. (b)(4). Pub. L. 105–115, § 119(a), added par. (4).
Subsec. (c)(4). Pub. L. 105–115, § 124(a), added par. (4).
Subsec. (d). Pub. L. 105–115, § 115(a), inserted at end “If the Secretary determines, based on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish effectiveness, the Secretary may consider such data and evidence to constitute substantial evidence for purposes of the preceding sentence.”
Subsec. (i). Pub. L. 105–115, § 117, inserted “(1)” after “(i)”, redesignated former pars. (1) to (3) as subpars. (A) to (C), respectively, of par. (1), added pars. (2) to (4), and struck out closing provisions which read as follows: “Such regulations shall provide that such exemption shall be conditioned upon the manufacturer, or the sponsor of the investigation, requiring that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where they deem it not feasible or, in their professional judgment, contrary to the best interests of such human beings. Nothing in this subsection shall be construed to require any clinical investigator to submit directly to the Secretary reports on the investigational use of drugs.”
Subsec. (j)(2)(A)(i). Pub. L. 105–115, § 119(b)(2)(A), substituted “paragraph (7)” for “paragraph (6)”.
Subsec. (j)(3). Pub. L. 105–115, § 119(b)(1)(B), added par. (3). Former par. (3) redesignated (4).
Subsec. (j)(4). Pub. L. 105–115, § 119(b)(1)(A), (2)(B), redesignated par. (3) as (4) and in introductory provisions substituted “paragraph (5)” for “paragraph (4)”. Former par. (4) redesignated (5).
Subsec. (j)(4)(I). Pub. L. 105–115, § 119(b)(2)(C), substituted “paragraph (6)” for “paragraph (5)”.
Subsec. (j)(5), (6). Pub. L. 105–115, § 119(b)(1)(A), redesignated pars. (4) and (5) as (5) and (6), respectively. Former par. (6) redesignated (7).
Subsec. (j)(7). Pub. L. 105–115, § 119(b)(1)(A), (2)(D), redesignated par. (6) as (7) and in subpar. (C) substituted “paragraph (6)” for “paragraph (5)” in two places. Former par. (7) redesignated (8).
Subsec. (j)(8), (9). Pub. L. 105–115, § 119(b)(1)(A), redesignated pars. (7) and (8) as (8) and (9), respectively.
Subsec. (n). Pub. L. 105–115, § 120, added subsec. (n).
1993—Subsec. (j)(6)(A)(ii). Pub. L. 103–80, § 3(n)(1)(A), substituted “Secretary” for “Secretry”.
Subsec. (j)(6)(A)(iii). Pub. L. 103–80, § 3(n)(1)(B), inserted comma after “published by the Secretary”.
Subsec. (k)(1). Pub. L. 103–80, § 3(n)(2), substituted “section. Regulations” for “section: Provided, however, That regulations”.
1992—Subsec. (j)(8). Pub. L. 102–282 added par. (8).
1984—Subsec. (a). Pub. L. 98–417, § 102(b)(1), inserted “or (j)” after “subsection (b)”.
Subsec. (b). Pub. L. 98–417, §§ 102(a)(1), 103(a), designated existing provisions of subsec. (b) as par. (1) thereof and redesignated existing cls. (1) through (6) of such par. (1) as cls. (A) through (F) thereof, respectively, inserted requirement that the applicant file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably by asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug, that the applicant amend the application to include such information if an application is filed under this subsection for a drug and a patent which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, and that upon approval of the application, the Secretary publish the information submitted, and added pars. (2) and (3).
Subsec. (c). Pub. L. 98–417, §§ 102(a)(2), (b)(2), 103(b), designated existing provisions of subsec. (c) as par. (1) thereof and in par. (1) as so designated substituted “subsection (b)” for “this subsection” and redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, and added pars. (2) and (3).
Subsec. (d)(6), (7). Pub. L. 98–417, § 102(a)(3)(A), added cl. (6) relating to the failure of the application to contain the patent information prescribed by subsec. (b) of this section, and redesignated former cl. (6) as (7).
Subsec. (e). Pub. L. 98–417, § 102(a)(3)(B), in first sentence, added a new cl. (4) relating to the failure to file the patent information prescribed by subsec. (c) of this section within 30 days after the receipt of written notice from the Secretary specifying the failure to file such information, and redesignated former cl. (4) as (5).
Pub. L. 98–417, § 102(b)(3), (4), in second sentence, inserted in provisions preceding cl. (1) “submitted under subsection (b) or (j)” and in cl. (1) substituted “under subsection (k) or to comply with the notice requirements of section 360(k)(2) of this title” for “under subsection (j) or to comply with the notice requirements of section 360(j)(2) of this title”.
Subsecs. (j), (k). Pub. L. 98–417, § 101, added subsec. (j) and redesignated former subsec. (j) as (k).
Subsec. (k)(1). Pub. L. 98–417, § 102(b)(5), substituted “under subsection (b) or (j)” for “pursuant to this section”.
Subsecs. (l), (m). Pub. L. 98–417, § 104, added subsecs. (l) and (m).
1972—Subsec. (e). Pub. L. 92–387 inserted “or to comply with the notice requirements of section 360(j)(2) of this title” in cl. (1) of second sentence relating to the maintenance of records.
1962—Subsec. (a). Pub. L. 87–781, § 104(a), inserted “an approval of” before “an application”.
Subsec. (b). Pub. L. 87–781, § 102(b), inserted “and whether such drug is effective in use” after “is safe for use”.
Subsec. (c). Pub. L. 87–781, § 104(b), substituted provisions requiring the Secretary, within 180 days after filing an application, or such additional period as the Secretary and the applicant agree upon, to either approve the application, if meeting the requirements of subsec. (d) of this section, or give notice of opportunity for hearing on question of whether such application is approvable, and providing that if applicant requests hearing in writing within 30 days, the hearing shall begin within 90 days after expiration of said 30 days, unless the Secretary and applicant agree otherwise, that such hearing shall be expedited, and that the Secretary’s order shall be issued within 90 days after date for filing final briefs, for provisions which had an application become effective on the sixtieth day after filing thereof unless prior thereto the Secretary postponed the date by written notice to such time, but not more than 180 days after filing, as the Secretary deemed necessary to study and investigate the application.
Subsec. (d). Pub. L. 87–781, § 102(c), inserted references to subsec. (c), added cls. (5) and (6), provided that if after notice and opportunity for hearing, the Secretary finds that cls. (1) to (6) do not apply, he shall approve the application, and defined “substantial evidence” as used in this subsection and subsec. (e) of this section.
Subsec. (e). Pub. L. 87–781, § 102(d), amended subsec. (e) generally, and among other changes, directed the Secretary to withdraw approval of an application if by tests, other scientific data or experience, or new evidence of clinical experience not contained in the application or available at the time of its approval, the drug is shown to be unsafe, or on the basis of new information, there is shown a lack of substantial evidence that the drug has the effect it is represented to have, and provided that if the Secretary, or acting Secretary, finds there is an imminent hazard to the public health, he may suspend approval immediately, notify the applicant, and give him opportunity for an expedited hearing, that the Secretary may withdraw approval if the applicant fails to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain records and make reports, or has refused access to, or copying or verification of such records, or if the Secretary finds on new evidence that the methods, facilities and controls in the manufacturing, processing, and packing are inadequate to assure and preserve the drugs’ identity, strength, quality and purity, and were not made adequate within a reasonable time after receipt of written notice thereof, or finds on new evidence, that the labeling is false or misleading and was not corrected within a reasonable time after receipt of written notice thereof.
Subsec. (f). Pub. L. 87–781, § 104(c), substituted provisions requiring the Secretary to revoke any previous order under subsecs. (d) or (e) of this section refusing, withdrawing, or suspending approval of an application and to approve such application or reinstate such approval, for provisions which required him to revoke an order refusing effectiveness to an application.
Subsec. (h). Pub. L. 87–781, § 104(d)(1), (2), inserted “as provided in section 2112 of title 28”, and “except that until the filing of the record the Secretary may modify or set aside his order”, substituted “or withdrawing approval of an application under this section” for “to permit the application to become effective, or suspending the effectiveness of the application”, “United States court of appeals for the circuit” for “district court of the United States within any district”, “Court of Appeals for the District of Columbia Circuit” for “District Court for the District of Columbia”, “transmitted by the clerk of the court to” for “served upon”, and “by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28” for “as provided in sections 225, 346, and 347 of title 28, as amended, and in section 7, as amended, of the Act entitled ‘An Act to establish a Court of Appeals for the District of Columbia’, approved
Subsec. (i). Pub. L. 87–781, § 103(b), inserted “the foregoing subsections of” after “operation of”, and “and effectiveness” after “safety”, and provided that the regulations may condition exemptions upon the submission of reports of preclinical tests to justify the proposed clinical testing, upon the obtaining by the manufacturer or sponsor of the investigation of a new drug of a signed agreement from each of the investigators that patients to whom the drug is administered will be under his supervision or under investigators responsible to him, and that he will not supply such drug to any other investigator, or to clinics, for administration to human beings, or upon the establishment and maintenance of records and reports of data obtained by the investigational use of such drug, as the Secretary finds will enable him to evaluate the safety and effectiveness of such drug, and provided that the regulations shall condition an exemption upon the manufacturer or sponsor of the investigation requiring that experts using such drugs certify that they will inform humans to whom such drugs or any controls connected therewith are administered, or their representatives, and will obtain the consent of such people where feasible and not contrary to the best interests of such people, and that reports on the investigational use of drugs are not required to be submitted directly to the Secretary.
Subsec. (j). Pub. L. 87–781, § 103(a), added subsec. (j).
1960—Subsec. (g). Pub. L. 86–507 inserted “or by certified mail” after “registered mail”.
Pub. L. 117–328, div. FF, title III, § 3602(c),
Pub. L. 116–290, § 2(d)(2),
Pub. L. 112–144, title XI, § 1134(b),
Pub. L. 110–85, title VII, § 701(c),
Amendment by sections 901(a), 903, and 905(a) of Pub. L. 110–85 effective 180 days after
Pub. L. 108–173, title XI, § 1101(c), “(1) Except as provided in paragraphs (2) and (3), the amendments made by subsections (a) and (b) [amending this section] apply to any proceeding under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) that is pending on or after the date of the enactment of this Act [“(2) The amendments made by subsections (a)(1) and (b)(1) apply with respect to any certification under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) submitted on or after “(3) The amendments made by subsections (a)(2)(A)(ii)(I) and (b)(2)(B)(i) apply with respect to any patent information submitted under subsection (b)(1) or (c)(2) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) on or after
Pub. L. 108–173, title XI, § 1102(b), “(1) Except as provided in paragraph (2), the amendment made by subsection (a) [amending this section] shall be effective only with respect to an application filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the date of the enactment of this Act [“(2) If a forfeiture event described in section 505(j)(5)(D)(i)(V) of that Act occurs in the case of an applicant, the applicant shall forfeit the 180-day period under section 505(j)(5)(B)(iv) of that Act without regard to when the first certification under section 505(j)(2)(A)(vii)(IV) of that Act for the listed drug was made.“(3) With respect to an application filed before, on, or after the date of the enactment of this Act [
Amendment by Pub. L. 108–155 effective
Amendment by Pub. L. 106–113 effective 4 months after
Amendment by Pub. L. 105–115 effective 90 days after
Pub. L. 98–417, title I, § 105, “(a) The Secretary of Health and Human Services shall promulgate, in accordance with the notice and comment requirements of section 553 of title 5, United States Code, such regulations as may be necessary for the administration of section 505 of the Federal Food, Drug, and Cosmetic Act [this section], as amended by sections 101, 102, and 103 of this Act, within one year of the date of enactment of this Act [“(b) During the period beginning sixty days after the date of the enactment of this Act [
Amendment by Pub. L. 92–387 effective on first day of sixth month beginning after
Amendment by Pub. L. 87–781 effective on first day of seventh calendar month following October 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.
Pub. L. 110–85, title IX, § 905(b),
Amendment by Pub. L. 102–282 not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this title.
Pub. L. 117–328, div. FF, title II, § 2512(a), “(1) the submission of stability testing data in such applications, including considerations for data requirements that could be streamlined or reduced to facilitate faster review of longer proposed expiration dates;“(2) establishing in the labeling of drugs the longest feasible expiration date scientifically supported by such data, taking into consideration how extended expiration dates may—“(A) help prevent or mitigate drug shortages; and“(B) affect product quality; and“(3) the use of innovative approaches for drug and combination product stability modeling to support initial product expiration dates and expiration date extensions.”
Pub. L. 117–328, div. FF, title III, § 3211, “(a) Not later than 3 years after the date of enactment of this Act [“(b) Not later than 18 months after the close of the public comment period on the draft guidance issued pursuant to subsection (a), the Secretary, acting through the Commissioner of Food and Drugs, shall finalize the draft guidance.“(c) To assist entities developing preventive vaccines for fungal infections and coccidioidomycosis, the Secretary shall hold a public workshop.”
Pub. L. 117–328, div. FF, title III, § 3602(a), (b), “(a) The Secretary [of Health and Human Services] shall update or issue guidance relating to—“(1) the format and content of the diversity action plans required by sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(z); 360j(g)(9)) (as amended by section 3601) pertaining to the sponsor’s goals for clinical study enrollment, disaggregated by age group, sex, and racial and ethnic demographic characteristics of clinically relevant study populations, and may include characteristics such as geographic location and socioeconomic status, including with respect to—“(A) the rationale for the sponsor’s enrollment goals, which may include—“(i) the estimated prevalence or incidence in the United States of the disease or condition for which the drug or device is being investigated in the relevant clinical trial, if such estimated prevalence or incidence is known or can be determined based on available data;“(ii) what is known about the disease or condition for which the drug or device is being investigated;“(iii) any relevant pharmacokinetic or pharmacogenomic data;“(iv) what is known about the patient population for such disease or condition, including, to the extent data is available— “(I) demographic information, which may include age group, sex, race, geographic location, socioeconomic status, and ethnicity; “(II) non-demographic factors, including co-morbidities affecting the patient population; and “(III) potential barriers to enrolling diverse participants, such as patient population size, geographic location, and socioeconomic status; and“(v) any other data or information relevant to selecting appropriate enrollment goals, disaggregated by demographic subgroup, such as the inclusion of pregnant and lactating women; and“(B) an explanation for how the sponsor intends to meet such goals, including demographic-specific outreach and enrollment strategies, study-site selection, clinical study inclusion and exclusion practices, and any diversity training for study personnel;“(2) submission of any modifications to the diversity action plan;“(3) considerations for the public posting by a sponsor of key information from the diversity action plan that would be useful to patients and providers on the sponsor’s website, as appropriate;“(4) criteria that the Secretary will consider in assessing whether to grant a sponsor’s request to waive the requirement to submit a diversity action plan under section 505(z)(4) or 520(g)(9)(C) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(z)(4), 360j(g)(9)(C)] (as amended by section 3601); and“(5) how sponsors may include in regular reports otherwise required by the Secretary—“(A) the sponsor’s progress in meeting the goals referred to in paragraph (1)(A); and“(B) any updates needed to be made to a diversity action plan referred to in paragraph (1) to help meet goals referred to in paragraph (1)(A); and“(C) if the sponsor does not expect to meet goals referred to in paragraph (1)(A), the sponsor’s reasons for why the sponsor does not expect to meet such goals.“(b) The Secretary shall—“(1) not later than 12 months after the date of enactment of this Act [“(2) not later than 9 months after closing the comment period on such draft guidance, finalize such guidance.”
Pub. L. 117–328, div. FF, title III, § 3604, “(a) Beginning not later than 2 years after the date of enactment of this Act [“(1) summarizes, in aggregate, the diversity action plans received pursuant to section 505(z) or 520(g)(9) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(z), 360j(g)(9)], as added by section 3601; and“(2) contains information, in the aggregate, on—“(A) for drugs, biological products, and devices approved, licensed, cleared, or classified under section 505, 515, 510(k), or 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355; 360e; 360(k); and 360(f)(2) [probably means “360c(f)(2)”]), or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)), whether the clinical studies conducted with respect to such applications met the demographic subgroup enrollment goals from the diversity action plan submitted for such applications; and“(B) the reasons provided, if any, for why enrollment goals from submitted diversity action plans were not met.“(b) Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.”
Pub. L. 117–328, div. FF, title III, § 3629, “(a) Not later than 1 year after the date of enactment of this Act [“(1) With respect to drugs, such guidance shall address the use of such data and evidence to support the approval of a drug application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or a biological product application under section 351 of the Public Health Service Act (42 U.S.C. 262), and to support an investigational use exemption submission under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or section 351(a)(3) of the Public Health Service Act (42 U.S.C. 262(a)(3)). Such guidance shall include considerations for the inclusion, in such applications and submissions, of real world data and real world evidence obtained as a result of the use of drugs authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3), and considerations for standards and methodologies for collection and analysis of real world evidence included in such applications and submissions, as appropriate.“(2) With respect to devices, such guidance shall address the use of such data and evidence to support the approval, clearance, or classification of a device pursuant to an application or submission submitted under section 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c(f)(2), 360e), to support an investigational use exemption submission under section 520(g) of such Act (21 U.S.C. 360j(g)), and to support a determination by the Secretary for purposes of section 353 of the Public Health Service Act (42 U.S.C. 263a) (including the category described under subsection (d)(3) of such section). Such guidance shall include considerations for the inclusion, in such applications and submissions, of real world data and real world evidence obtained as a result of the use of devices authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3), including considerations related to a determination under section 353(d)(3) of the Public Health Service Act (42 U.S.C. 263a(d)(3)), and considerations for standards and methodologies for collection and analysis of real world evidence included in such applications, submissions, or determinations, as appropriate.“(b) Not later than 2 years after the end of the public health emergency declared by the Secretary under section 319 of the Public Health Service Act (42 U.S.C. 247d) on “(1) the number of applications, submissions, or requests submitted for clearance, approval, or authorization under section 505, 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360c(f)(2), 360e) or section 351 of the Public Health Service Act (42 U.S.C. 262), for which an authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) was previously granted;“(2) of the number of applications so submitted, the number of such applications—“(A) for which real world evidence was submitted and used to support a regulatory decision; and“(B) for which real world evidence was submitted and determined to be insufficient to support a regulatory decision; and“(3) a summary explanation of why, in the case of applications described in paragraph (2)(B), real world evidence could not be used to support regulatory decisions.“(c) Nothing in this section shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 1905 of title 18, United States Code, or subject to withholding under subsection (b)(4) of section 552 of title 5, United States Code (commonly referred to as the ‘Freedom of Information Act’).”
Pub. L. 115–271, title III, § 3001, “(a) Not later than one year after the date of enactment of this Act [“(1) the manner by which the Secretary may incorporate the risks of misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) into the risk benefit assessments under subsections (d) and (e) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), section 510(k) of such Act (21 U.S.C. 360(k)), or section 515(c) of such Act (21 U.S.C. 360e(c)), as applicable;“(2) the application of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255) [set out as a note below]), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), and use of patient experience data (consistent with section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c)) for the development of non-addictive medical products intended to treat pain or addiction;“(3) the evidentiary standards and the development of opioid-sparing data for inclusion in the labeling of medical products intended to treat acute or chronic pain; and“(4) the application of eligibility criteria under sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) for non-addictive medical products intended to treat pain or addiction.“(b) Not less than one year after the public meetings are conducted under subsection (a) the Secretary shall issue one or more final guidance documents, or update existing guidance documents, to help address challenges to developing non-addictive medical products to treat pain or addiction. Such guidance documents shall include information regarding—“(1) how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the Secretary—“(A) may apply the eligibility criteria under such sections 506 and 515B to non-addictive medical products intended to treat pain or addiction;“(B) considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and“(C) considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition;“(2) the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence;“(3) the manner in which the Food and Drug Administration will assess evidence to support the inclusion of opioid-sparing data in the labeling of non-addictive medical products intended to treat acute or chronic pain, including—“(A) alternative data collection methodologies, including the use of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255) [set out as a note below]) and real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), including patient registries and patient reported outcomes, as appropriate, to support product labeling;“(B) ethical considerations of exposing subjects to controlled substances in clinical trials to develop opioid-sparing data and considerations on data collection methods that reduce harm, which may include the reduction of opioid use as a clinical benefit;“(C) endpoints, including primary, secondary, and surrogate endpoints, to evaluate the reduction of opioid use;“(D) best practices for communication between sponsors and the agency on the development of data collection methods, including the initiation of data collection; and“(E) the appropriate format in which to submit such data results to the Secretary; and“(4) the circumstances under which the Food and Drug Administration considers misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) in making the risk benefit assessment under paragraphs (2) and (4) of subsection (d) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and in finding that a drug is unsafe under paragraph (1) or (2) of subsection (e) of such section.“(c) In this section—“(1) the term ‘medical product’ means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))); and“(2) the term ‘opioid-sparing’ means reducing, replacing, or avoiding the use of opioids or other controlled substances intended to treat acute or chronic pain.”
Pub. L. 115–271, title III, § 3041(c),
Pub. L. 115–52, title IX, § 902, “(1) The median time following a request from staff of the Food and Drug Administration reviewing an application or report to the beginning of the inspection, including—“(A) the median time for drugs described in 505(j)(11)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(11)(A)(i));“(B) the median time for drugs for which a notification has been submitted in accordance with section 506C(a) of such Act (21 U.S.C. 356c(a)) during the previous fiscal year; and“(C) the median time for drugs on the drug shortage list in effect under section 506E of such Act (21 U.S.C. 356e) at the time of such request.“(2) The median time from the issuance of a report pursuant to section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(b)) to the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting for inspections for which the Secretary concluded that regulatory or enforcement action was indicated, including the median time for each category of drugs listed in subparagraphs (A) through (C) of paragraph (1).“(3) The median time from the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting related to conditions observed by the Secretary during an inspection, to the time at which the Secretary concludes that corrective actions to resolve such conditions have been taken.“(4) The number of facilities that failed to implement adequate corrective or preventive actions following a report issued pursuant to such section 704(b), resulting in a withhold recommendation for an application under review, including the number of such facilities manufacturing each category of drugs listed in subparagraphs (A) through (C) of paragraph (1).”
Pub. L. 114–255, div. A, title III, § 3004,
Pub. L. 114–255, div. A, title III, § 3021, “(a) For purposes of assisting sponsors in incorporating complex adaptive and other novel trial designs into proposed clinical protocols and applications for new drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and biological products under section 351 of the Public Health Service Act (42 U.S.C. 262), the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall conduct a public meeting and issue guidance in accordance with subsection (b).“(b) “(1) The Secretary, acting through the Commissioner of Food and Drugs, shall update or issue guidance addressing the use of complex adaptive and other novel trial design in the development and regulatory review and approval or licensure for drugs and biological products.“(2) The guidance under paragraph (1) shall address—“(A) the use of complex adaptive and other novel trial designs, including how such clinical trials proposed or submitted help to satisfy the substantial evidence standard under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));“(B) how sponsors may obtain feedback from the Secretary on technical issues related to modeling and simulations prior to—“(i) completion of such modeling or simulations; or“(ii) the submission of resulting information to the Secretary;“(C) the types of quantitative and qualitative information that should be submitted for review; and“(D) recommended analysis methodologies.“(3) Prior to updating or issuing the guidance required by paragraph (1), the Secretary shall consult with stakeholders, including representatives of regulated industry, academia, patient advocacy organizations, consumer groups, and disease research foundations, through a public meeting to be held not later than 18 months after the date of enactment of this Act [“(4) The Secretary shall update or issue a draft version of the guidance required by paragraph (1) not later than 18 months after the date of the public meeting required by paragraph (3) and finalize such guidance not later than 1 year after the date on which the public comment period for the draft guidance closes.”
Pub. L. 114–255, div. A, title III, § 3038(c),
Pub. L. 114–198, title I, § 106(a), “(1) “(A) Subject to subparagraph (B), prior to the approval pursuant to an application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) of a new drug that is an opioid, the Secretary of Health and Human Services (referred to in this section [enacting provisions set out as notes under this section and section 355–1 of this title] as the ‘Secretary’) shall refer the application to an advisory committee of the Food and Drug Administration to seek recommendations from such advisory committee.“(B) A referral to an advisory committee under subparagraph (A) is not required with respect to a new opioid drug or drugs if the Secretary—“(i) finds that such a referral is not in the interest of protecting and promoting public health;“(ii) finds that such a referral is not necessary based on a review of the relevant scientific information; and“(iii) submits a notice containing the rationale for such findings to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.“(2) The Secretary shall convene the Pediatric Advisory Committee of the Food and Drug Administration to seek recommendations from such Committee regarding a framework for the inclusion of information in the labeling of drugs that are opioids relating to the use of such drugs in pediatric populations before the Secretary approves any labeling or change to labeling for any drug that is an opioid intended for use in a pediatric population.“(3) The requirements of paragraphs (1) and (2) shall cease to be effective on
Pub. L. 114–198, title I, § 106(c),
Pub. L. 112–144, title VIII, § 806, “(a) Not later than “(1) specifies how preclinical and clinical data can be utilized to inform an efficient and streamlined pathogen-focused antibacterial drug development program that meets the approval standards of the Food and Drug Administration; and“(2) provides advice on approaches for the development of antibacterial drugs that target a more limited spectrum of pathogens.“(b) Not later than
Pub. L. 112–144, title XI, § 1122(c),
Pub. L. 112–144, title XI, § 1133, “(a) “(1) If a first applicant files an application during the 30-month period ending on the date of enactment of this Act [“(A) during the period beginning on the date of enactment of this Act, and ending on “(B) during the period beginning on “(2) In the case of an application to which an extended period under paragraph (1) applies, the reference to the 30-month period under section 505(q)(1)(G) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(1)(G)) shall be read to be the applicable period under paragraph (1).“(b) If an application is filed on or before the date of enactment of this Act [“(c) For the purposes of this section, the terms ‘application’ and ‘first applicant’ mean application and first applicant, as such terms are used in section 505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(IV)).”
Pub. L. 110–85, title IX, § 907,
Pub. L. 108–173, title XI, § 1103(b),
Pub. L. 108–173, title XI, subtitle B, “Any filing required under section 1112 shall be filed with the Assistant Attorney General and the Commission not later than 10 business days after the date the agreements are executed. “Any information or documentary material filed with the Assistant Attorney General or the Commission pursuant to this subtitle shall be exempt from disclosure under section 552 of title 5, United States Code, and no such information or documentary material may be made public, except as may be relevant to any administrative or judicial action or proceeding. Nothing in this section is intended to prevent disclosure to either body of the Congress or to any duly authorized committee or subcommittee of the Congress. “Any action taken by the Assistant Attorney General or the Commission, or any failure of the Assistant Attorney General or the Commission to take action, under this subtitle shall not at any time bar any proceeding or any action with respect to any agreement between a brand name drug company and a generic drug applicant or a biosimilar biological product applicant, any agreement between generic drug applicants, or any agreement between biosimilar biological product applicants, under any other provision of law, nor shall any filing under this subtitle constitute or create a presumption of any violation of any competition laws.“SEC. 1111. DEFINITIONS.“In this subtitle:“(1) ANDA.—The term ‘ANDA’ means an abbreviated drug application, as defined under section 201(aa) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(aa)].“(2) The term ‘Assistant Attorney General’ means the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice.“(3) The term ‘biosimilar biological product’ means a biological product for which a biosimilar biological product application under section 351(k) of the Public Health Service Act [42 U.S.C. 262(k)] is approved.“(4) The term ‘biosimilar biological product applicant’ means a person who has filed or received approval for a biosimilar biological product application under section 351(k) of the Public Health Service Act [42 U.S.C. 262(k)].“(5) The term ‘biosimilar biological product application’ means an application under section 351(k) of the Public Health Service Act [42 U.S.C. 262(k)] for licensure of a biological product as biosimilar to, or interchangeable with, a reference product.“(6) The term ‘brand name drug’ means a drug for which an application is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(c)], including an application referred to in section 505(b)(2) of such Act [21 U.S.C. 355(b)(2)], or a biological product for which an application is approved under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)].“(7) The term ‘brand name drug company’ means the party that holds the approved application referred to in paragraph (6) for a brand name drug that is a listed drug in an ANDA or a reference product in a biosimilar biological product application, or a party that is the owner of a patent for which information is submitted for such drug under subsection (b) or (c) of section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(b), (c)] or the owner, or exclusive licensee, of a patent included in a list provided under section 351(l)(3) of the Public Health Service Act [42 U.S.C. 262(l)(3)].“(8) The term ‘Commission’ means the Federal Trade Commission.“(9) The term ‘generic drug’ means a drug for which an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)] is approved.“(10) The term ‘generic drug applicant’ means a person who has filed or received approval for an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)].“(11) The term ‘listed drug’ means a brand name drug that is listed under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)(7)].“(12) The term ‘reference product’ has the meaning given such term in section 351(i) of the Public Health Service Act [42 U.S.C. 262(i)].“SEC. 1112. NOTIFICATION OF AGREEMENTS.“(a) “(1) A generic drug applicant that has submitted an ANDA containing a certification under section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)(2)(A)(vii)(IV)] or a biosimilar biological product applicant who has submitted a biosimilar biological product application and a brand name drug company that enter into an agreement described in paragraph (2) shall each file the agreement in accordance with subsection (c). The agreement shall be filed prior to the date of the first commercial marketing of the generic drug that is the subject of the ANDA or the biosimilar biological product that is the subject of the biosimilar biological product application, as applicable.“(2) An agreement described in this paragraph between a generic drug applicant or a biosimilar biological product applicant and a brand name drug company is an agreement regarding—“(A) the manufacture, marketing, or sale of the brand name drug that is the listed drug in the ANDA or the reference product in the biosimilar biological product application involved;“(B) the manufacture, marketing, or sale of the generic drug for which the ANDA was submitted or of the biosimilar biological product for which the biosimilar biological product application was submitted; or“(C) as applicable—“(i) the 180-day period referred to in section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)(5)(B)(iv)] as it applies to such ANDA or to any other ANDA based on the same listed drug; or“(ii) any of the time periods referred to in section 351(k)(6) of the Public Health Service Act [42 U.S.C. 262(k)(6)] as such period applies to such biosimilar biological product application or to any other biosimilar biological product application based on the same reference product.“(b) “(1) “(A) A generic drug applicant that has submitted an ANDA containing a certification under section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)(2)(A)(vii)(IV)] with respect to a listed drug and another generic drug applicant that has submitted an ANDA containing such a certification for the same listed drug shall each file the agreement in accordance with subsection (c). The agreement shall be filed prior to the date of the first commercial marketing of either of the generic drugs for which such ANDAs were submitted.“(B) A biosimilar biological product applicant that has submitted a biosimilar biological product application that references a reference product and another biosimilar biological product applicant that has submitted a biosimilar biological product application that references the same reference product shall each file the agreement in accordance with subsection (c). The agreement shall be filed prior to the date of the first commercial marketing of either of the biosimilar biological products for which such biosimilar biological product applications were submitted.“(2) An agreement described in this paragraph is, as applicable, an agreement between 2 or more generic drug applicants regarding the 180-day period referred to in section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)(5)(B)(iv)] as it applies to the ANDAs with which the agreement is concerned,, [sic] an agreement between 2 or more biosimilar biological product applicants regarding a time period referred to in section 351(k)(6) of the Public Health Service Act [42 U.S.C. 262(k)(6)] as it applies to the biosimilar biological product, or an agreement between 2 or more biosimilar biological product applicants regarding the manufacture, marketing, or sale of a biosimilar biological product.“(c) “(1) The parties that are required in subsection (a) or (b) to file an agreement in accordance with this subsection shall file with the Assistant Attorney General and the Commission the text of any such agreement, except that such parties are not required to file an agreement that solely concerns—“(A) purchase orders for raw material supplies;“(B) equipment and facility contracts;“(C) employment or consulting contracts; or“(D) packaging and labeling contracts.“(2) The parties that are required in subsection (a) or (b) to file an agreement in accordance with this subsection shall file with the Assistant Attorney General and the Commission the text of any agreements between the parties that are not described in such subsections and are contingent upon, provide a contingent condition for, were entered into within 30 days of, or are otherwise related to an agreement that is required in subsection (a) or (b) to be filed in accordance with this subsection.“(3) In the event that any agreement required in subsection (a) or (b) to be filed in accordance with this subsection has not been reduced to text, each of the parties involved shall file written descriptions of such agreement that are sufficient to disclose all the terms and conditions of the agreement.“SEC. 1113. FILING DEADLINES.“SEC. 1114. DISCLOSURE EXEMPTION.“SEC. 1115. ENFORCEMENT.“(a) Any brand name drug company, generic drug applicant, or biosimilar biological product applicant which fails to comply with any provision of this subtitle shall be liable for a civil penalty of not more than $11,000, for each day during which such entity is in violation of this subtitle. Such penalty may be recovered in a civil action brought by the United States, or brought by the Commission in accordance with the procedures established in section 16(a)(1) of the Federal Trade Commission Act (15 U.S.C. 56(a) [15 U.S.C. 56(a)(1)]).“(b) If any brand name drug company, generic drug applicant, or biosimilar biological product applicant fails to comply with any provision of this subtitle, the United States district court may order compliance, and may grant such other equitable relief as the court in its discretion determines necessary or appropriate, upon application of the Assistant Attorney General or the Commission.“SEC. 1116. RULEMAKING.“The Commission, with the concurrence of the Assistant Attorney General and by rule in accordance with section 553 of title 5, United States Code, consistent with the purposes of this subtitle—“(1) may define the terms used in this subtitle;“(2) may exempt classes of persons or agreements from the requirements of this subtitle; and“(3) may prescribe such other rules as may be necessary and appropriate to carry out the purposes of this subtitle.“SEC. 1117. SAVINGS CLAUSE.“SEC. 1118. EFFECTIVE DATE.“This subtitle shall—“(1) take effect 30 days after the date of the enactment of this Act [“(2) shall apply to agreements described in section 1112 that are entered into 30 days after the date of the enactment of this Act.”
Pub. L. 107–109, § 15(d),
Pub. L. 105–115, title I, § 118,
Pub. L. 105–115, title I, § 121(c), “(1) “(A) In order to take account of the special characteristics of positron emission tomography drugs and the special techniques and processes required to produce these drugs, not later than 2 years after the date of enactment of this Act [“(i) appropriate procedures for the approval of positron emission tomography drugs pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and“(ii) appropriate current good manufacturing practice requirements for such drugs.“(B) In establishing the procedures and requirements required by subparagraph (A), the Secretary of Health and Human Services shall take due account of any relevant differences between not-for-profit institutions that compound the drugs for their patients and commercial manufacturers of the drugs. Prior to establishing the procedures and requirements, the Secretary of Health and Human Services shall consult with patient advocacy groups, professional associations, manufacturers, and physicians and scientists licensed to make or use positron emission tomography drugs.“(2) “(A) Except as provided in subparagraph (B), the Secretary of Health and Human Services shall not require the submission of new drug applications or abbreviated new drug applications under subsection (b) or (j) of section 505 (21 U.S.C. 355), for compounded positron emission tomography drugs that are not adulterated drugs described in section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) (as amended by subsection (b)), for a period of 4 years after the date of enactment of this Act [“(B) Nothing in this Act [see Short Title of 1997 Amendment note set out under section 301 of this title] shall prohibit the voluntary submission of such applications or the review of such applications by the Secretary of Health and Human Services. Nothing in this Act shall constitute an exemption for a positron emission tomography drug from the requirements of regulations issued under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)).”
“Compounded Positron Emission Topography Drug” Defined
Pub. L. 105–115, title I, § 121(e),
Pub. L. 105–115, title I, § 122, “(a) “(1) “(A) Not later than 180 days after the date of enactment of this Act [“(B) Not later than 18 months after the date of enactment of this Act, the Secretary shall promulgate final regulations governing the approval of the radiopharmaceuticals.“(2) In the case of a radiopharmaceutical, the indications for which such radiopharmaceutical is approved for marketing may, in appropriate cases, refer to manifestations of disease (such as biochemical, physiological, anatomic, or pathological processes) common to, or present in, one or more disease states.“(b) In this section, the term ‘radiopharmaceutical’ means—“(1) an article—“(A) that is intended for use in the diagnosis or monitoring of a disease or a manifestation of a disease in humans; and“(B) that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons; or“(2) any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of any such article.”
Pub. L. 105–115, title I, § 123(f),
Pub. L. 110–379, § 4(b), “(1) With respect to a patent issued on or before the date of the enactment of this Act [“(2) With respect to any patent information referred to in paragraph (1) of this subsection that is filed with the Secretary within the 60-day period after the date of the enactment of this Act [“(3) With respect to any patent information referred to in paragraph (1) that is filed with the Secretary within the 60-day period after the date of enactment of this Act [
Pub. L. 105–115, title I, § 125(d), “(1) An application that was approved by the Secretary of Health and Human Services before the date of the enactment of this Act [“(2) The following subsections of section 505 (21 U.S.C. 355) shall not apply to any application for marketing in which the drug that is the subject of the application contains an antibiotic drug and the antibiotic drug was the subject of any application for marketing received by the Secretary of Health and Human Services under section 507 of such Act (21 U.S.C. 357) before the date of the enactment of this Act [“(A)(i) Subsections (c)(2), (d)(6), (e)(4), (j)(2)(A)(vii), (j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), and (j)(4)(D); and“(ii) The third and fourth sentences of subsection (b)(1) (regarding the filing and publication of patent information); and“(B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and (c)(3) if the investigations relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted.“(3) For purposes of this section, the Secretary is authorized to make available to the public the established name of each antibiotic drug that was the subject of any application for marketing received by the Secretary for Health and Human Services under section 507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357) before the date of enactment of this Act [
Advisory panels established after
Pub. L. 87–781, title I, § 104(d)(3),
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.