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Designation of an Orphan Drug | Midpage
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Code of Federal Regulations
Title 21
Chapter I
Subchapter D
Part 316
Subpart C
Designation of an Orphan Drug
316.20
Content and format of a request for orphan-drug designation.
316.21
Verification of orphan-drug status.
316.22
Permanent-resident agent for foreign sponsor.
316.23
Timing of requests for orphan-drug designation; designation of already approved drugs.
316.24
Deficiency letters and granting orphan-drug designation.
316.25
Refusal to grant orphan-drug designation.
316.26
Amendment to orphan-drug designation.
316.27
Change in ownership of orphan-drug designation.
316.28
Publication of orphan-drug designations.
316.29
Revocation of orphan-drug designation.
316.30
Annual reports of holder of orphan-drug designation.