FDA Budget Request Proposes OTC Monograph User Fees And ‘Field Alerts’
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.
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FDA’s food, dietary supplement and cosmetics division seeks funding to support its artificial intelligence capabilities, including post-market surveillance and speedy interventions in instances where safety issues arise. Also of note, the agency cites UV filters’ effects on the skin microbiome as a research priority in its fiscal 2021 budget justification to Congress.
Senate's Over-the-Counter Monograph Safety, Innovation, and Reform Act goes next for consideration by House, which has had a bill by the same title on its floor for a vote since it was passed by Energy and Commerce Committee in late June.
Agency’s approach to risk-based postmarketing safety surveillance explained in new draft document issued under the 21st Century Cures Act; product characteristics and intended use guide the frequency and extent of adverse event report screening, with newer drugs undergoing weekly reviews for three years after approval.