Federal (United States) · Regulations
Part 314 — APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
58 sections
8 groups
- Subpart A — General Provisions1 section
- Subpart B — Applications8 sections
- Subpart C — Abbreviated Applications6 sections
- Subpart D — FDA Action on Applications and Abbreviated Applications22 sections
- Subpart E — Hearing Procedures for New Drugs3 sections
- Subpart G — Miscellaneous Provisions5 sections
- Subpart H — Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses7 sections
- Subpart I — Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible6 sections