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U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

All TitlesTitle 21Chapter IPart 312Subpart C - Subpart C—Administrative Actions
§ 312.40 - General requirements for use of an investigational new drug in a clinical investigation.
§ 312.41 - Comment and advice on an IND.
§ 312.42 - Clinical holds and requests for modification.
§ 312.44 - Termination.
§ 312.45 - Inactive status.
§ 312.47 - Meetings.
§ 312.48 - Dispute resolution.
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