e-CFR 21 PART 316 Orphan Drug & the Orphan Drug Act 1983
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21 Code Federal Regulations Part 316 - Orphan Drugs
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Public Law 97-414 To amend Federal Food, Drug, and Cosmetic Act to facilitate the development of drugs for rare diseases and conditions in PDF
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Summary of H.R. 5238 - 97th Congress (1981-1982) Orphan Drug Act