Orphan Drugs

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs for Human Use
  6. Orphan Drugs

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Subpart
A

General Provisions

Subpart
B

Written Recommendations for Investigations of Orphan Drugs

Subpart
C

Designation of an Orphan Drug

Subpart
D

Orphan-drug Exclusive Approval

Subpart
E

Open Protocols for Investigations

Subpart
F

Availability of Information