2016 US Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
Subchapter III - Prohibited Acts and Penalties
Sec. 335c - Authority to withdraw approval of abbreviated drug applications
| 21 U.S.C. § 335c (2016) |
| §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. The Secretary may not take any action under subsection (a) with respect to any person unless the Secretary has issued an order for such action made on the record after opportunity for an agency hearing on disputed issues of material fact. In the course of any investigation or hearing under this subsection, the Secretary may administer oaths and affirmations, examine witnesses, receive evidence, and issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation. (c) ApplicabilitySubsection (a) shall apply with respect to offenses or acts regardless of when such offenses or acts occurred. (d) Judicial reviewAny person that is the subject of an adverse decision under subsection (a) may obtain a review of such decision by the United States Court of Appeals for the District of Columbia or for the circuit in which the person resides, by filing in such court (within 60 days following the date the person is notified of the Secretary's decision) a petition requesting that the decision be modified or set aside. |
|
(June 25, 1938, ch. 675, §308, as added Pub. L. 102–282, §4, May 13, 1992, 106 Stat. 160.) |
|
CONSTRUCTION
This section 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. |
| United States Code, 2012 Edition, Supplement 4, Title 21 - FOOD AND DRUGS |
| Bills and Statutes |
| United States Code |
| Y 1.2/5: |
| Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES Sec. 335c - Authority to withdraw approval of abbreviated drug applications |
| section 335c |
| 2016 |
| January 6, 2017 |
| No |
| standard |
| 106 Stat. 160 |
| Public Law 102-282 |
