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FDA Floats OTC Monograph Overhaul To Be “More Agile And Responsive”

 
• By Malcolm Spicer

The agency will conduct a public hearing March 25-26 for comments about improving the OTC monograph process, which currently faces “significant challenges.” FDA’s proposals include expanding the process for allowing deviations from formulations approved through NDAs and issuing monographs by administrative order.

FDA is seeking to overhaul its OTC drug monograph process to be “more agile and responsive,” noting the current system faces “significant challenges.”

The agency will conduct a public hearing on March 25 and 26 at the agency’s headquarters in Silver Spring, Md., for comments about improving the OTC Drug Review, or OTC monograph process, according to a Federal Register

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