What Is the Purpose of the Orphan Drug Act?

Matthew Herder suggests it may be time to re-examine the purpose of the U.S. Orphan Drug Act.

Vyšlo v časopise: What Is the Purpose of the Orphan Drug Act?. PLoS Med 14(1): e32767. doi:10.1371/journal.pmed.1002191
Kategorie: Perspective
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1002191

Souhrn

Matthew Herder suggests it may be time to re-examine the purpose of the U.S. Orphan Drug Act.

Zdroje

1. Orphan Drug Act of 1983. Pub L. No. 97–414, 96 Stat. 2049.

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10. Waxman HA. The history and development of the Orphan Drug Act. In: Scheinberg IH, Walsh JM, editors. Orphan Diseases and Orphan Drugs. Manchester University Press; 1986.

11. Orphan Drug Act of 1983, Pub. L. No. 97–414, 96 Stat 2049 (Jan. 4, 1983). § 526(a)(2).

12. Health Promotion and Disease Prevention Amendments of 1984, Pub. L. 98–551, 98 Stat 2815 (1984), § 4.

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16. Orphan Drug Regulations (Final Rule) 57 Fed. Reg. 62,076 (Dec. 29, 1992).

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18. Orphan Drug Regulations (Final Rule) 78 Fed. Reg. 35,117 (June 12, 2013).

19. Warren KS. The great neglected diseases of mankind, or All the world's an orphanage. In: Scheinberg IH, Walshe JM, editors. Orphan Diseases and Orphan Drugs. Manchester University Press; 1986.

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