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-d-orphan-drug-exclusive-approval/31631-scope-of-orphan-drug-exclusive-approval?ref=AsVVwS!2JSaJb
Timestamp: 2020-05-28 15:53:50
Document Index: 271308000

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

§ 316.31 Scope of orphan-drug exclusive approval, 21 C.F.R. § 316.31 | Casetext Search + Citator
Title 21 - Food and DrugsCHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)SUBCHAPTER D - DRUGS FOR HUMAN USEPART 316 - ORPHAN DRUGS
Subpart D - Orphan-drug Exclusive Approval
§ 316.31 Scope of orphan-drug exclusive approval
21 C.F.R. § 316.31
(4) Failure of the holder of exclusive approval to assure a sufficient quantity of the drug under section 527 of the act and § 316.36.
§ 316.34 FDA recognition of exclusive approval