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.
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Last of 32 OTC monographs finalized as required in 2020 reform legislation as some stakeholders ask if the agency is collecting user fees yet.
“The nonprescription drug space has been a bit challenging over the past two to three years as a result of the pandemic,” says CDER director Patrizia Cavazzoni.
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.