21 CFR 314.2 - Purpose.

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There is 1 rule appearing in the Federal Register for 21 CFR 314. View below or at eCFR (GPOAccess)
§ 314.2 Purpose.
The purpose of this part is to establish an efficient and thorough drug review process in order to: (a) Facilitate the approval of drugs shown to be safe and effective; and (b) ensure the disapproval of drugs not shown to be safe and effective. These regulations are also intended to establish an effective system for FDA's surveillance of marketed drugs. These regulations shall be construed in light of these objectives.

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.

  • 2014-06-10; vol. 79 # 111 - Tuesday, June 10, 2014
    1. 79 FR 33072 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective June 10, 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 314 after this date.

  • 2014-06-10; vol. 79 # 111 - Tuesday, June 10, 2014
    1. 79 FR 33072 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective June 10, 2015.
      21 CFR Parts 310, 314, 329, and 600