What Orphan Drug Act of 1983, Section 526 - Designation of Orphan Drugs requires
The Orphan Drug Act of 1983, Section 526, requires the FDA to designate a drug as an orphan drug if it is intended for the treatment…
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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: 27cddefa043eca5cb589e6db6bfcf2decdf4dac4adfbda1c14f75895bce01f82
Primary Citations — 5 traced to source
- Orphan Drug Act of 1983, Section 526(a)(1) - Definition of Orphan Drug
- Orphan Drug Act of 1983, Section 526(a)(2) - Requirements for Orphan Drug Designation
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