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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 B
21 CFR Subpart B
Written Recommendations for Investigations of Orphan Drugs
June 25, 2020
§
316.10
Content and format of a request for written recommendations
§
316.12
Providing written recommendations
§
316.14
Refusal to provide written recommendations
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