21 CFR Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
- Subpart A - General Provisions (§§ 314.1 - 314.3)
- Subpart B - Applications (§§ 314.50 - 314.90)
- Subpart C - Abbreviated Applications (§§ 314.92 - 314.99)
- Subpart D - FDA Action on Applications and Abbreviated Applications (§§ 314.100 - 314.170)
- Subpart E - Hearing Procedures for New Drugs (§§ 314.200 - 314.235)
- Subpart F [Reserved]
- Subpart G - Miscellaneous Provisions (§§ 314.410 - 314.445)
- Subpart H - Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses (§§ 314.500 - 314.560)
- Subpart I - Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible (§§ 314.600 - 314.650)