21 CFR 314.2 - Purpose.

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§ 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 2015-04-01

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

  • 2015-07-08; vol. 80 # 130 - Wednesday, July 8, 2015
    1. 80 FR 38915 - Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      The rule is effective September 8, 2015.
      21 CFR Parts 20, 310, 314, and 600