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.
21 CFR Part 314 · Applications for FDA Approval to Market a New Drug
§ 314.2 Purpose
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Amendment history
Federal Register documents that created or amended this section.
- 50 FR 7493 22 Feb 1985