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FDA Budget Request Proposes OTC Monograph User Fees And ‘Field Alerts’

 
• By Malcolm Spicer

In addition proposing $28.4m in monograph user fees, agency’s FY 2021 budget justification includes among its legislative initiatives proposing to require "Field Alert Reports" for drug products not marketed under an approved application, such as monograph OTCs.

White House Budget book

The US Food and Drug Administration for the third consecutive year includes OTC monograph user fees in its budget request, but in its fiscal year 2021 proposal the agency for the first time suggests extending its “Field Alert Reports” requirement to monograph OTCs.

The agency’s document submitted to Congress as justification for its FY 2021 budget request includes in its list of legislative initiatives proposing to require Field Alert Reports (FARs) for drug...

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