StacksVerified U.S. regulatory reference

21 CFR §516.24

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)FDA may grant the request for MUMS-drug designation if none of the reasons described in § 516.25 for refusal to grant such a request apply.
  2. (b)When a request for MUMS-drug designation is granted, FDA will notify the sponsor in writing and will give public notice of the MUMS-drug designation in accordance with § 516.28.