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. 21 CFR Subpart H
21 CFR Subpart H
Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
June 25, 2020
§
314.550
Promotional materials
§
314.500
Scope
§
314.510
Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity
§
314.520
Approval with restrictions to assure safe use
§
314.530
Withdrawal procedures
§
314.540
Postmarketing safety reporting
§
314.560
Termination of requirements
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Subpart E Hearing Procedures for New Drugs
Next
Subpart I Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible

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