What 21 CFR Part 314 - Applications for FDA Approval to Market a New Drug requires
This regulation outlines the requirements for submitting, amending, and maintaining applications…
This is a preview. The full record adds the complete summary, 9 workflow steps, 9 schema fields and 7 primary citations. Start a free trial or see pricing.
Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-314
SHA-256 integrity: f1ac36e00f1d41420978720dd9a806a0dfbc0183fa8be9c1c53e739ac9140e03
Primary Citations — 7 traced to source
- § 314.50 Content and format of an NDA.
- § 314.53 Submission of patent information.
+ 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-cfr-21-part-314-new-drug-applications.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/us-fda-cfr-21-part-314-new-drug-applications.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/us-fda-cfr-21-part-314-new-drug-applications
- Back to registry: Browse all 10,102 compliance nodes