Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA issues final rule on good manufacturing practices for combination products. Rule withdrawn on scientific misconduct policy. More regulatory news.
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Regulatory News In Brief
IMDRF releases three new proposed guidance documents. FDA is accepting comments on its plans to accept electronic submissions for device recalls. More regulatory news.
Device Industry Seeks More Clarity Following Combo Product GMP Final Rule
FDA’s final regulation outlines which manufacturing system requirements apply to products that have drug, device and/or biologic components. The Combination Products Coalition says key details need to be filled in by FDA with guidance.
Industry Seeks More Clarity Following Combo Product GMP Final Rule
FDA’s final regulation outlines which manufacturing system requirements apply to products that have drug, device and/or biologic components. An industry coalition says key details need to be filled in by FDA with guidance.