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U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

All TitlesTitle 21Chapter IPart 310Subpart A - Subpart A—General Provisions
§ 310.3 - Definitions and interpretations.
§ 310.4 - Biologics; products subject to license control.
§ 310.6 - Applicability of “new drug” or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products.
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