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Title 21

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eCFR Content

Editorial codification of the general and permanent rules published in the Federal Register.

Title 21 Food and Drugs Part / Section
Chapter I Food and Drug Administration, Department of Health and Human Services 1 – 1299
Subchapter D Drugs for Human Use 300 – 499
Part 314 Applications for FDA Approval to Market a New Drug 314.1 – 314.650
Subpart A General Provisions 314.1 – 314.3
§ 314.1 Scope of this part.
§ 314.2 Purpose.
§ 314.3 Definitions.
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
§ 314.200 Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing.
§ 314.201 Procedure for hearings.
§ 314.235 Judicial review.
Subpart F [Reserved]
Subpart G Miscellaneous Provisions 314.410 – 314.445
§ 314.410 Imports and exports of new drugs.
§ 314.420 Drug master files.
§ 314.430 Availability for public disclosure of data and information in an application or abbreviated application.
§ 314.440 Addresses for applications and abbreviated applications.
§ 314.445 Guidance documents.
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