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

 
• By Malcolm Spicer

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.

• Source: Shutterstock

The first 12 requests the US Food and Drug Administration received for meetings to discuss proposals for OTC monograph changes during fiscal year 2023 will start something all the subsequent requests won’t – a clock ticking on the agency’s response.

Although already accepting requests, the Center for Drug Evaluation and Research’s Office of Nonprescription Drugs won’t start responding until FY2023...

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