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U.S Code last checked for updates: Nov 22, 2024
All Titles
Title 21
Chapter 9
Subchapter III
§ 335b. Civil penalties...
§ 336. Report of minor violation...
§ 335b. Civil penalties...
§ 336. Report of minor violation...
U.S. Code
Notes
§ 335c.
Authority to withdraw approval of abbreviated drug applications
(a)
In general
The Secretary—
(1)
shall withdraw approval of an abbreviated drug application if the Secretary finds that the approval was obtained, expedited, or otherwise facilitated through bribery, payment of an illegal gratuity, or fraud or material false statement, and
(2)
may withdraw approval of an abbreviated drug application if the Secretary finds that the applicant has repeatedly demonstrated a lack of ability to produce the drug for which the application was submitted in accordance with the formulations or manufacturing practice set forth in the abbreviated drug application and has introduced, or attempted to introduce, such adulterated or misbranded drug into commerce.
(b)
Procedure
(c)
Applicability
(d)
Judicial review
(
June 25, 1938, ch. 675, § 308
, as added
Pub. L. 102–282, § 4
,
May 13, 1992
,
106 Stat. 160
.)
cite as:
21 USC 335c
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