The House yesterday voted 392-28 to pass legislation (H.R. 7667) that would reauthorize Food and Drug Administration user fee programs, which provide funding for the agency to review drugs, devices and biologics. Among other provisions, the bipartisan bill would include drugs on the FDA’s shortages list in a pilot program to designate advanced manufacturing technologies. The Senate Health, Education, Labor, and Pensions Committee will mark up their version of the bill Tuesday.

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The Food and Drug Administration has identified a Class I recall of certain convenience kits by AVID Medical that contain recalled Medline Namic Angiographic…
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The Food and Drug Administration has issued an early alert for all automated Impella controllers by Abiomed following an issue that has caused three deaths and…
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Boston Scientific, a large supplier of medical devices, said in an Aug. 26 statement posted on its website that on Aug. 25 it “identified a cybersecurity…
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The Food and Drug Administration has issued early alerts for the following products: •    Certain epidural kits by Medical Action…
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The Food and Drug Administration has identified a Class I recall of certain Medline convenience kits containing B. Braun components that have Huons Bupivacaine…
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The Food and Drug Administration is seeking public feedback on a discussion paper released today on potential regulatory approaches for generative artificial…