Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 316--ORPHAN DRUGS

TEXT PDF316.1 Scope of this part.
TEXT PDF316.2 Purpose.
TEXT PDF316.3 Definitions.
TEXT PDF316.4 Address for submissions.
TEXT PDF316.10 Content and format of a request for written recommendations.
TEXT PDF316.12 Providing written recommendations.
TEXT PDF316.14 Refusal to provide written recommendations.
TEXT PDF316.20 Content and format of a request for orphan-drug designation.
TEXT PDF316.21 Verification of orphan-drug status.
TEXT PDF316.22 Permanent-resident agent for foreign sponsor.
TEXT PDF316.23 Timing of requests for orphan-drug designation; designation of already approved drugs.
TEXT PDF316.24 Granting orphan-drug designation.
TEXT PDF316.25 Refusal to grant orphan-drug designation.
TEXT PDF316.26 Amendment to orphan-drug designation.
TEXT PDF316.27 Change in ownership of orphan-drug designation.
TEXT PDF316.28 Publication of orphan-drug designations.
TEXT PDF316.29 Revocation of orphan-drug designation.
TEXT PDF316.30 Annual reports of holder of orphan-drug designation.
TEXT PDF316.31 Scope of orphan-drug exclusive approval.
TEXT PDF316.34 FDA recognition of exclusive approval.
TEXT PDF316.36 Insufficient quantities of orphan drugs.
TEXT PDF316.40 Treatment use of a designated orphan drug.
TEXT PDF316.50 Guidance documents.
TEXT PDF316.52 Availability for public disclosure of data and information in requests and applications.

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