21 CFR 314.1 - Scope of this part.

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§ 314.1 Scope of this part.
(a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under section 505 of the Federal Food, Drug, and Cosmetic Act, as well as amendments, supplements, and postmarketing reports to them.
(b) This part does not apply to drug products subject to licensing by FDA under the Public Health Service Act (58 Stat. 632 as amended (42 U.S.C. 201 et seq.)) and subchapter F of chapter I of title 21 of the Code of Federal Regulations.
(c) References in this part to regulations in the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
[50 FR 7493, Feb. 22, 1985, as amended at 57 FR 17981, Apr. 28, 1992; 64 FR 401, Jan. 5, 1999]

Title 21 published on 2014-04-01.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2015-05-27; vol. 80 # 101 - Wednesday, May 27, 2015
    1. 80 FR 30151 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Delay of Compliance Date; Safety Reporting Portal of Electronic Submission of Postmarketing Safety Reports for Human Drugs and Nonvaccine Biological Products
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; delay of compliance date.
      Effective Date: This final rule is effective June 10, 2015. Compliance Date: The compliance date for the final rule published at 79 FR 33072 on June 10, 2014, is delayed until September 8, 2015.
      21 CFR Parts 310, 314, 329, and 600

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 314 after this date.

  • 2015-05-27; vol. 80 # 101 - Wednesday, May 27, 2015
    1. 80 FR 30151 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Delay of Compliance Date; Safety Reporting Portal of Electronic Submission of Postmarketing Safety Reports for Human Drugs and Nonvaccine Biological Products
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; delay of compliance date.
      Effective Date: This final rule is effective June 10, 2015. Compliance Date: The compliance date for the final rule published at 79 FR 33072 on June 10, 2014, is delayed until September 8, 2015.
      21 CFR Parts 310, 314, 329, and 600