Source: https://casetext.com/regulation/code-of-federal-regulations/title-21-food-and-drugs/chapter-i-food-and-drug-administration-department-of-health-and-human-services-continued/subchapter-d-drugs-for-human-use/part-316-orphan-drugs/subpart-a-general-provisions/3163-definitions?ref=AsVVwS!R5tcfd
Timestamp: 2019-08-23 00:31:32
Document Index: 190868761

Matched Legal Cases: ['§ 316', '§ 316', '§ 316', '§ 316', '§ 316', '§ 316']

§ 316.3 Definitions, 21 C.F.R. § 316.3 | Casetext
21 C.F.R. § 316.3
§ 316.3 Definitions
ReadReadAnnotationsAnnotations0Attorney AnalysesAnalyses9Citing BriefsBriefs1Citing CasesCiting Cases10
(13) Orphan subset of a non-rare disease or condition (“orphan subset”) means that use of the drug in a subset of persons with a non-rare disease or condition may be appropriate but use of the drug outside of that subset (in the remaining persons with the non-rare disease or condition) would be inappropriate owing to some property(ies) of the drug, for example, drug toxicity, mechanism of action, or previous clinical experience with the drug.
§ 316.2 Purpose
§ 316.4 Address for submissions