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U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

All TitlesTitle 21Chapter IPart 312Subpart A - Subpart A—General Provisions
§ 312.1 - Scope.
§ 312.2 - Applicability.
§ 312.3 - Definitions and interpretations.
§ 312.6 - Labeling of an investigational new drug.
§ 312.7 - Promotion of investigational drugs.
§ 312.8 - Charging for investigational drugs under an IND.
§ 312.10 - Waivers.
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