§ 516.23. Timing of requests for MUMS-drug designation.
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/us/cfr/t21/s§ 516.23·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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.