21 CFR 516.23 - Timing of requests for MUMS-drug designation.

Regulations last checked for updates: Feb 16, 2025

Title 21 - Food and Drugs last revised: Feb 03, 2025

View all text of Subpart B [§ 516.11 - § 516.52]

§ 516.23 - Timing of requests for MUMS-drug designation.

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.

authority: 21 U.S.C. 360ccc-1,360ccc,371

source: 72 FR 41017, July 26, 2007, unless otherwise noted.

cite as: 21 CFR 516.23