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 defined by the Orphan Drug Act. Sponsors must submit a request with supporting data to the FDA, which grants designation independently from approval or licensing, per the Orphan Drug Act and 21 CFR Part 316.
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: 31fcaa92572a06892f5f9732f4d548c8e81a5322ee76f77eb7b3c2e939a0b5e3
Primary Citations — 5 traced to source
- Orphan Drug Act, Public Law 97-414
- 21 Code Federal Regulations Part 316 - Orphan Drugs
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