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In a step rarely taken by the agency, the FDA today has proposed a ban of electrical stimulation devices (ESD) intended to reduce or stop self-injurious or aggressive behavior because the agency has determined that these devices present an unreasonable and substantial risk of illness or injury. 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
A week following the EPA’s announced new rules for facilities emitting cancer-causing ethylene oxide (EtO), FDA officials urged consensus standards be developed and broadly accepted for medical device sterilization protocols and premarket submissions. Read More
The FTC has filed an amicus brief in a suit between Teva Pharmaceuticals and Amneal Pharmaceuticals, supporting Amneal and saying Teva has improperly listed the patents in dispute in the FDA’s Orange Book, and urged the court to order Teva’s listings removed. Read More
All but one of the five experts testifying at the hearing agreed that the field of LDTs would be irreparably harmed by the FDA’s proposed rule. Read More
An FDA advisory committee on Thursday gave its unanimous blessing to Balance Opthalmics’ FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) system as a nightly use adjunct therapy for reducing intraocular pressure in adults with open-angle glaucoma and intraocular pressure 21 mmHg or less. Read More
The FDA has identified product recalls for Vyaire’s AirLife Manual Resuscitators and for the use instructions for Abiomed’s left-sided heart pumps as Class I, while device manufacturer InfuTronix is voluntarily recalling its line of Nimbus Infusion Pumps after design flaws prompted thousands of customer complaints. Read More
Over the past week, the FDA published a draft rule on drug products that present demonstrable difficulties for compounding. Final guidance was issued on controlled correspondence for generic drug development. Draft guidance on real-world evidence in drug and biological products’ non-interventional studies was also issued. Read More
Sol-Millennium, one of the three syringe manufacturers called out in a March 19 FDA Safety Communication for potential device failures, says it is “confident” that it can resolve all issues identified in an FDA Warning Letter. Read More
Those who work with laboratory developed tests (LDT) would have much preferred their rapidly developing field be regulated by the Verifying Accurate, Leading-edge IVCT Development (VALID) Act — but since Congress has repeatedly failed to pass the bipartisan act, the field is now reeling at the “overreach” of the FDA’s new proposed rule on regulating LDTs. Read More
This edition of Quick Notes reviews Becton Dickinson’s increase in U.S. manufacturing of syringes, clearance of the twiist Automated Insulin Delivery system, a new indication for Amplify standalone bone graft putty, and Fujifilm’s AI-powered endoscopic imaging technology. Read More