US OTC Monograph Reform's Early Results Could Be Label Orders From FDA, Wait And See For Industry
With much of FDA's work currently focused on the COVID-19 pandemic, the agency has limited resources available to implement monograph changes authorized by recent legislation. Drug firms awaited a monograph overhaul with expectations for success where they previously failed, but they need FDA's guidance to succeed.
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Payments FDA receives could expand from facility fees between $13,548 and $20,322 collected from around 1,700 firms for the current fiscal year to include payments of $500,000 or $100,000 from firms for proposed monograph changes.
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