The Food and Drug Administration’s Clinical Decision Support (CDS) Software guidance published 18 September 2022 violated procedural law and should be rescinded, said CDS Coalition legal counsel Bradley Thompson.
Petition Argues FDA’s CDS Software Guidance Violates The Law
CDS Coalition legal counsel Bradley Thompson broke down the citizen petition calling for the US FDA to rescind the Clinical Decision Software guidance based on legal and procedural violations.
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Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.
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