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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
All Titles
Title 21
Chapter I
Part 316
Subpart B - Subpart B—Written Recommendations for Investigations of Orphan Drugs
§ 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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