How US FDA Wants Pharmaceutical Production Volumes Reported For Drug Shortage Prevention
Monthly data are expected in annual reports on listed drugs and active ingredients from every registered site, starting in February.
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Objections to 15 February reporting date established in draft guidance spurred rare last-minute notice assuring industry that it was a non-binding recommendation, not a requirement.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.
The COVID-19 pandemic has both caused problems such as reduced preventive maintenance and exacerbated other issues, such as slowing recovery from extreme weather events, according to Resilinc CEO.
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.