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…

A drug manufacturing facility with ungowned, barefoot employees received an FDA Warning Letter that cited “insanitary conditions” in the production of sterile ophthalmic drug products, and was among the manufacturers…

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. Source: Drug Industry Daily

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…

In its first annual report, the CDER Office of Communications pointed to its three main goals, all of which focus on supporting the public’s faith in the FDA to protect…

Many drug developers could improve the alignment of their quality units and their business units — and potentially avoid Form 483 inspection observations — if they dusted off and applied…

Following ample input and data provided by the FDA, HHS has issued a white paper detailing its progress in reducing what it labels a “decades-long public health issue” — drug…

Most cancer drugs that gain an Accelerated Approval don’t end up showing any clinical benefit in their confirmatory trials, exposing thousands of patients to ineffective therapeutics that may linger on…

Supernus Pharmaceuticals and IntelGenx have recently received Complete Response Letters (CRL) from the FDA requesting additional quality information on their drug-device combination products. Source: Drug Industry Daily

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…