What Is the Purpose of the Orphan Drug Act?

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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).

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