What US 21 CFR Part 314: Applications for FDA Approval to Market a New Drug requires
US 21 CFR Part 314 sets requirements for New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) submissions to FDA for marketing approval. The regulation covers NDA content (clinical and nonclinical studies, CMC, labelling, patent information), review timelines, approval letters and refuse-to-file determinations, postmarketing requirements (REMS, post-approval studies, annual reports), generic ANDA bioequivalence demonstration, and 505(b)(2) hybrid applications. Compliance is the final regulatory milestone for US drug marketing.
Pillar: Pharmaceuticals & Life Sciences · Authority: US Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-314
SHA-256 integrity: 71c75c503f002c064e6fad1be8c6677df11fc58d6a1d470d33e771f523141c3c
Primary Citations — 5 traced to source
- Title 21 Code of Federal Regulations Part 314 Applications for FDA Approval to Market a New Drug
- Title 21 Code of Federal Regulations Part 312 Investigational New Drug Application
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