What US Orphan Drug Act (21 USC ch 9): Incentives for Rare Disease Drugs requires
The Orphan Drug Act, codified within the Federal Food, Drug, and Cosmetic Act (21 U.S.C. ch. 9, sections 360aa to 360ff), creates incentives to develop drugs for rare diseases or conditions, administered by the Food and Drug…
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Pillar: Pharmaceuticals & Life Sciences · Authority: US Congress / Food and Drug Administration · Version: 1.0.0 · Last updated:
Primary source: https://www.govinfo.gov/content/pkg/USCODE-2022-title21/html/USCODE-2022-title21-chap9.htm
SHA-256 integrity: d61e3ba8eb52a29bb4c4839eae5c076ff220c71ac62678f436d3aded1888ef7f
Primary Citations — 8 traced to source
- Orphan Drug Act, 21 U.S.C. 360aa - recommendations for investigations of drugs for rare diseases or conditions.
- Orphan Drug Act, 21 U.S.C. 360bb - designation of drugs for rare diseases or conditions.
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