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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
Three industry groups responding to a Senate committee’s March 14 RFI distributed to stakeholders showed no support for the FDA’s plan to regulate laboratory developed tests. Read More
This edition of Quick Notes reviews the FDA’s approval of Abbott’s transcatheter repair system, Spirair’s nasal septal deviation correction device, de novo approval of Orthobond’s antibacterial coating, and 510(k) clearance of Olympus’ single use ureteroscope system. Read More
Supernus Pharmaceuticals and IntelGenx have recently received Complete Response Letters (CRL) from the FDA requesting additional quality information on their drug-device combination products. 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