21 CFR § 516.23 New Animal Drugs for Minor Use and Minor Species

§ 516.23 Timing of requests for MUMS-drug designation.

Current through Sep 8, 2026 · Read all of Part 516

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.

← § 516.22 Permanent-resident U.S. agent for foreign sponsor.§ 516.24 Granting MUMS-drug designation. →