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.
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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.
Authorization was a long time coming for FDA to reform OTC monograph program and streamline process to change formulations, indications or labeling for large majority of drugs available nonprescription. As program is overhauled, monograph updates may seem to be coming just as slowly.
Final guidance presents same descriptions of six "categories of homeopathic drug products ... potentially posing higher risks to public health” agency stated in 2019 revised draft. Agency adds reference to monograph reform in explanation of how homeopathics aren't GRASE.