What Designating an Orphan Product: Drugs and Biological Products requires
This regulation establishes the process for sponsors to request orphan drug designation for drugs or biological products intended to prevent, diagnose, or treat rare diseases or conditions, as…
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Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.1 · Last updated:
Primary source: https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products
SHA-256 integrity: 269e5a0997905db5573eb594b0388b286271164e8a9207df3880d5de89bcf705
Primary Citations — 5 traced to source
- Orphan Drug Act, Public Law 97-414
- 21 Code Federal Regulations Part 316 - Orphan Drugs
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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