21 USC 356b - Reports of postmarketing studies

U.S Code last checked for updates: Nov 22, 2024

§ 356b.

Reports of postmarketing studies

(a)

Submission

(1)

In general

(2)

Accelerated approval

(3)

Agreements prior to effective date

(b)

Consideration of information as public information

Any information pertaining to a report described in subsection (a) shall be considered to be public information to the extent that the information is necessary—

(1)

to identify the sponsor; and

(2)

to establish the status of a study described in subsection (a) and the reasons, if any, for any failure to carry out the study.

(c)

Status of studies and reports

The Secretary shall annually develop and publish in the Federal Register a report that provides information on the status of the postmarketing studies—

(1)

that sponsors have entered into agreements to conduct; and

(2)

for which reports have been submitted under subsection (a)(1).

(d)

Disclosure

(e)

Notification

(June 25, 1938, ch. 675, § 506B, as added Pub. L. 105–115, title I, § 130(a), Nov. 21, 1997, 111 Stat. 2331; amended Pub. L. 107–188, title V, § 506, June 12, 2002, 116 Stat. 693; Pub. L. 112–144, title IX, § 902(c), July 9, 2012, 126 Stat. 1088; Pub. L. 117–328, div. FF, title III, § 3210(b), Dec. 29, 2022, 136 Stat. 5823.)

cite as: 21 USC 356b