21 C.F.R. PART 316--ORPHAN DRUGS
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
PART 316--ORPHAN DRUGS
Subpart A--GENERAL PROVISIONS
Subpart B--WRITTEN RECOMMENDATIONS FOR INVESTIGATIONS OF ORPHAN DRUGS
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| Content and format of a request for written recommendations.
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| Providing written recommendations.
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| Refusal to provide written recommendations.
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Subpart C--DESIGNATION OF AN ORPHAN DRUG
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| Content and format of a request for orphan-drug designation.
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| Verification of orphan-drug status.
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| Permanent-resident agent for foreign sponsor.
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| Timing of requests for orphan-drug designation; designation of already approved drugs.
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| Granting orphan-drug designation.
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| Refusal to grant orphan-drug designation.
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| Amendment to orphan-drug designation.
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| Change in ownership of orphan-drug designation.
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| Publication of orphan-drug designations.
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| Revocation of orphan-drug designation.
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| Annual reports of holder of orphan-drug designation.
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Subpart D--ORPHAN-DRUG EXCLUSIVE APPROVAL
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| Scope of orphan-drug exclusive approval.
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| FDA recognition of exclusive approval.
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| Insufficient quantities of orphan drugs.
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Subpart E--OPEN PROTOCOLS FOR INVESTIGATIONS
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| Treatment use of a designated orphan drug.
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Subpart F--AVAILABILITY OF INFORMATION
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| Availability for public disclosure of data and information in requests and applications.
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