1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter D - DRUGS FOR HUMAN USE
  5. Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
  6. Subpart D - FDA Action on Applications and Abbreviated Applications
  7. 21 CFR § 314.160
21 CFR § 314.160
Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn
June 25, 2020
CFR

Upon the Food and Drug Administration's own initiative or upon request of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the Federal Register announcing the approval.

[57 FR 17995, Apr. 28, 1992]

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§ 314.153 Suspension of approval of an abbreviated new drug application
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§ 314.161 Determination of reasons for voluntary withdrawal of a listed drug

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