FDA Email Alert: Next Day’s Manufacturing Volume Reporting Due Date Still Voluntary
Objections to 15 February reporting date established in draft guidance spurred rare last-minute notice assuring industry that it was a non-binding recommendation, not a requirement. Action reflects confusion that can arise in interpreting policy guidance.
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Manufacturers could risk losing FDA product approvals if they fail to publicize sourcing and quality information, under new proposals. National Academies expert panel says supply chain transparency – not a pandemic-induced rush to onshoring requirements – provides the framework to mitigate against and respond to drug shortages.
Comments cite requests for delayed or phased implementation, question how data will be used, and ask whether current reporting avenues could be used to gather similar information, among other concerns.
Monthly data are expected in annual reports on listed drugs and active ingredients from every registered site, starting in February.