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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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.
FDA also imposes import alert on lip balms, hand sanitizers and sunscreens made by Ningbo HuiZe Commodity in Zhejiang, China. Alert subjects products to detention without physical examination at US international ports of entry.