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 issued an early alert for all heart pump controllers by Abiomed, which sent a correction notice to all customers with…
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The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy…
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The Cybersecurity and Infrastructure Security Agency and other federal agencies released a joint guide yesterday for organizations to apply zero…
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The Food and Drug Administration has identified a nationwide recall. Arrow International is recommending dialysis catheter kits containing Merit Medical 16F…
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The Food and Drug Administration has issued an early alert for certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines by B.…
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The Administration for Strategic Preparedness and Response has launched a $100 million competition to support the development of antiviral drug therapies…