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

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 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.