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Section 316.1
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Purpose |
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Section 316.2
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Definitions |
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Section 316.3
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Address for submissions |
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Section 316.4
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Content and format of a request for written recommendations |
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Section 316.10
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Providing written recommendations |
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Section 316.12
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Refusal to provide written recommendations |
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Section 316.14
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Content and format of a request for orphan-drug designation |
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Section 316.20
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Verification of orphan-drug status |
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Section 316.21
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Permanent-resident agent for foreign sponsor |
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Section 316.22
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Timing of requests for orphan-drug designation; designation of already approved drugs |
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Section 316.23
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Deficiency letters and granting orphan-drug designation |
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Section 316.24
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Refusal to grant orphan-drug designation |
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Section 316.25
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Amendment to orphan-drug designation |
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Section 316.26
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Change in ownership of orphan-drug designation |
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Section 316.27
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Publication of orphan-drug designations |
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Section 316.28
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Revocation of orphan-drug designation |
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Section 316.29
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Annual reports of holder of orphan-drug designation |
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Section 316.30
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Scope of orphan-drug exclusive approval |
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Section 316.31
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FDA recognition of exclusive approval |
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Section 316.34
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Insufficient quantities of orphan drugs |
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Section 316.36
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Treatment use of a designated orphan drug |
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Section 316.40
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Guidance documents |
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Section 316.50
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Availability for public disclosure of data and information in requests and applications |
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Section 316.52
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List of qualifying pathogens that have the potential to pose a serious threat to public health |