Code of Federal Regulations > Title 21 > Chapter I > Part 314 - PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

Subpart A [§ 314.1 - § 314.3] - Subpart A—General Provisions

Subpart B [§ 314.50 - § 314.90] - Subpart B—Applications

Subpart C [§ 314.92 - § 314.99] - Subpart C—Abbreviated Applications

Subpart D [§ 314.100 - § 314.170] - Subpart D—FDA Action on Applications and Abbreviated Applications

Subpart E [§ 314.200 - § 314.235] - Subpart E—Hearing Procedures for New Drugs

Subpart F - Subpart F [Reserved]

Subpart G [§ 314.410 - § 314.445] - Subpart G—Miscellaneous Provisions

Subpart H [§ 314.500 - § 314.560] - Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses

Subpart I [§ 314.600 - § 314.650] - Subpart I—Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible