What New Drug Applications: Chemistry-Manufacturing-Controls, Clinical Data Requirements, Labelling and Post-Marketing Commitments requires
This regulation requires new drug applicants to submit a New Drug Application (NDA) that includes chemistry, manufacturing, and controls information, as well as clinical data, labeling, and post-marketing commitments, as outlined in 21 CFR 314.50. It applies to any person who intends to market a new drug in the United States.
Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration · Version: 1.0.1 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-314
SHA-256 integrity: fe637d25d52ac1557ce0f01de99915b90271ac571fbd81c5ee507b360ba30a32
Primary Citations — 5 traced to source
- 21 CFR 314.50 - Content and Format of an Application
- 21 CFR 314.80 - Postmarketing Reporting of Adverse Drug Experiences
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- Discovery (free): /api/v1/nodes/fda-21-cfr-part-314-nda-new-drug-application.json — 6-field metadata
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