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Timers Start Ticking At US FDA In A Month For An Even Dozen OTC Monograph Meeting Requests

Executive Summary

CDER Office of Nonprescription Drugs already accepts requests but won’t start responding until FY2023 begins on 1 October, also the start of FDA’s first year meeting with firms developing monograph changes and evaluating submitted proposals under deadlines included in program overhaul Congress authorized in 2020.

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