Orphan-drug Exclusive Approval

  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
  7. Orphan-drug Exclusive Approval

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Section
316.31

Scope of orphan-drug exclusive approval.

Section
316.34

FDA recognition of exclusive approval.

Section
316.36

Insufficient quantities of orphan drugs.