21 CFR Part 314, Subpart I - Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible

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There are 6 Updates appearing in the Federal Register for 21 CFR Part 314. View below or at eCFR (GPOAccess)

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