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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 312 - INVESTIGATIONAL NEW DRUG APPLICATION
21 CFR Subpart I
21 CFR Subpart I
Expanded Access to Investigational Drugs for Treatment Use
June 25, 2020
§
312.300
General
§
312.305
Requirements for all expanded access uses
§
312.310
Individual patients, including for emergency use
§
312.315
Intermediate-size patient populations
§
312.320
Treatment IND or treatment protocol
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