Granting MUMS-drug designation.

21 C.F.R. § 516.24
in effectEffective: 2024-07-01
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(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. (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.

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