Designation of an Orphan Drug

  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. Designation of an Orphan Drug

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Section
316.20

Content and format of a request for orphan-drug designation.

Section
316.21

Verification of orphan-drug status.

Section
316.22

Permanent-resident agent for foreign sponsor.

Section
316.23

Timing of requests for orphan-drug designation; designation of already approved drugs.

Section
316.24

Deficiency letters and granting orphan-drug designation.

Section
316.25

Refusal to grant orphan-drug designation.

Section
316.26

Amendment to orphan-drug designation.

Section
316.27

Change in ownership of orphan-drug designation.

Section
316.28

Publication of orphan-drug designations.

Section
316.29

Revocation of orphan-drug designation.

Section
316.30

Annual reports of holder of orphan-drug designation.