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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 B
21 CFR Subpart B
Investigational New Drug Application (IND)
June 25, 2020
§
312.20
Requirement for an IND
§
312.21
Phases of an investigation
§
312.22
General principles of the IND submission
§
312.23
IND content and format
§
312.30
Protocol amendments
§
312.31
Information amendments
§
312.32
IND safety reporting
§
312.33
Annual reports
§
312.38
Withdrawal of an IND
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