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The Abbott/Thoratec recall of HeartMate II and HeartMate 3 left ventricular assist system (LVAS) has been deemed Class I, the most serious type of recall, by the FDA. Read More
Of the $341 million increase in funding requested for the FDA in President Biden’s FY 2025 budget proposal, $114 million is needed to fund FDA employees’ 5 percent inflation pay increases for both this year and next, according to the agency’s chief financial officer (CFO). Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Less than a month after issuing warning letters to a China-based manufacturer of plastic syringes for various quality and branding violations, the FDA is suggesting U.S. providers and consumers avoid the products altogether. Read More
The FDA is hamstrung from truly mitigating impending drug supply shortages because the agency can’t get a consistently transparent view into drug manufacturers’ operations, FDA Commissioner Robert Califf told the House Committee on Oversight and Accountability during a nearly five-hour hearing on Thursday. Read More
A general sampling of comments received on the RFI do not reflect overwhelming support for the agency to regulate laboratory developed tests. Read More
A consent decree of permanent injunction against Philips Respironics restricting the production and sale of new CPAP and BiPAP machines and mechanical ventilators at three U.S. facilities has been entered by the U.S. District Court for the Western District of Pennsylvania. Read More