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Code of Federal Regulations (Last Updated: November 8, 2024)

Title 21 - Food and Drugs

Chapter I - Food and Drug Administration, Department of Health and Human Services

SubChapter D - Drugs for Human Use

Part 310 - New Drugs

Subpart A - General Provisions

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.