§ 314.2 Purpose.

FederalRegulations

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Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE > PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG > Subpart A—General Provisions

This text was captured on Sep 22, 2026. It is a snapshot, not a live feed, so check the official code before relying on it.

Text

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.

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