Manufacturer's 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. Manufacturer's Submissions, Requests, and Applications

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Section
99.201

Manufacturer's submission to the agency.

Section
99.203

Request to extend the time for completing planned studies.

Section
99.205

Application for exemption from the requirement to file a supplemental application.