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 E - Hearing Procedures for New Drugs
  7. 21 CFR § 314.201
21 CFR § 314.201
Procedure for hearings
June 25, 2020
CFR

Parts 10 through 16 apply to hearings relating to new drugs under section 505 (d) and (e) of the act.

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§ 314.200 Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing

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