What Applications for FDA Approval to Market a New Drug requires
This regulation establishes the requirements for submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) under 21 U.S.C…
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Pillar: Pharmaceuticals & Life Sciences · Authority: Food and Drug Administration, Department of Health and Human Services · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-314
SHA-256 integrity: aabce5b36f5140157965afcc6da85a78c25f52d854d8e5d3206d4729332a5192
Primary Citations — 7 traced to source
- 21 CFR 314.50 - Content and format of an NDA
- 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences
+ 5 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/us-fda-21-cfr-314-nda-application.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/us-fda-21-cfr-314-nda-application.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/us-fda-21-cfr-314-nda-application
- Back to registry: Browse all 10,102 compliance nodes