21 CFR 516.23

§ 516.23 Timing of requests for MUMS-drug designation.

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

Cite this

Citation: 21 CFR 516.23, § 516.23 Timing of requests for MUMS-drug designation, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87005
Permanent ID: ys:prov:87005@1
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Full text

A sponsor may request MUMS-drug designation at any time in the drug development process prior to the submission of an application for either conditional approval or approval of the MUMS drug for which designation is being requested.

Legislative history

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