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Applications for FDA Approval to Market a New Drug

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs for Human Use
  6. Applications for FDA Approval to Market a New Drug

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Subpart
A

General Provisions

Subpart
B

Applications

Subpart
C

Abbreviated Applications

Subpart
D

FDA Action on Applications and Abbreviated Applications

Subpart
E

Hearing Procedures for New Drugs

Subpart
F

Subpart F [Reserved]

Subpart
G

Miscellaneous Provisions

Subpart
H

Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses

Subpart
I

Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible

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