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Title 21 - Title 21
Part 316 - ORPHAN DRUGS
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Details about Part 316
Description
DRUGS FOR HUMAN USE - ORPHAN DRUGS
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24 sections
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§316.1 - Scope of this part.
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§316.10 - Content and format of a request for written recommendations.
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§316.12 - Providing written recommendations.
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§316.14 - Refusal to provide written recommendations.
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§316.2 - Purpose.
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§316.20 - Content and format of a request for orphan-drug designation.
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§316.21 - Verification of orphan-drug status.
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§316.22 - Permanent-resident agent for foreign sponsor.
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§316.23 - Timing of requests for orphan-drug designation; designation of already approved drugs.
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§316.24 - Deficiency letters and granting orphan-drug designation.
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§316.25 - Refusal to grant orphan-drug designation.
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§316.26 - Amendment to orphan-drug designation.
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§316.27 - Change in ownership of orphan-drug designation.
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§316.28 - Publication of orphan-drug designations.
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§316.29 - Revocation of orphan-drug designation.
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§316.3 - Definitions.
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§316.30 - Annual reports of holder of orphan-drug designation.
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§316.31 - Scope of orphan-drug exclusive approval.
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§316.34 - FDA recognition of exclusive approval.
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§316.36 - Insufficient quantities of orphan drugs.
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§316.4 - Address for submissions.
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§316.40 - Treatment use of a designated orphan drug.
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§316.50 - Guidance documents.
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§316.52 - Availability for public disclosure of data and information in requests and applications.
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