21 CFR 314.500

§ 314.500 Scope.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 314.500, § 314.500 Scope, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86391
Permanent ID: ys:prov:86391@1
SHA-256: fe6748bd4cbd329693bf95431a7160d169c835b13bc327ef18ef68cf703b2271

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Full text

This subpart applies to certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.