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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
21 CFR Subpart D
21 CFR Subpart D
Orphan-drug Exclusive Approval
June 25, 2020
§
316.31
Scope of orphan-drug exclusive approval
§
316.34
FDA recognition of exclusive approval
§
316.36
Insufficient quantities of orphan drugs
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