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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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US FDA Adds Pediatric Cough/Cold Dosing, Ipecac GRASE To Latest OTC Monograph Forecast

Latest plan, agency’s second annual following debut in 2021, lists monograph activities FDA intends to address over next three years. “FDA’s decision‐making regarding which activities to place on the forecast is generally guided by public health priorities,” it says.

US OTC Monograph Reform Enters Electronic Age With Draft Guidance On Submission Formats

Submissions go to one of two addresses: OMORs, for changes or additions to monograph formulations and indications, go to the CDER NextGen Portal, and data, information and public comments on proposed or interim final orders go to OTC Monographs@FDA.

With More OTC Drugs On Radar, US FDA Reminds Industry Of Statement Of Identity Requirements

Draft guidances published on statements of OTC drug identity and strength and on labeling of sodium, potassium and phosphorous levels. Recommendations come as agency and drug industry anticipate more OTC remedies becoming available through proposed ACNU rule and streamlined monograph program.

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