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.
You may also be interested in...
US FDA Catches Up On Monograph Petitions: Denies Antiseptic TFM Requests Made In 2001
Agency’s recent responses denying three petitions filed in 2001 by US industry trade groups and in 2002 by pharmaceutical ingredient and chemicals firm explain the changes requested can be proposed in “OTC monograph order requests” pathway established in program overhaul.
Timers Start Ticking At US FDA In A Month For An Even Dozen OTC Monograph Meeting Requests
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.
US FDA Meets Initial Deadlines In OTC Monograph Overhaul While It's Rebuilding The Program
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.