FDA Action on Submissions, Requests, and Applications

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. General
  6. Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
  7. FDA Action on Submissions, Requests, and Applications

Checkout our iOS App for a better way to browser and research.

Section
99.301

Agency action on a submission.

Section
99.303

Extension of time for completing planned studies.

Section
99.305

Exemption from the requirement to file a supplemental application.