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…
This edition of Quick Notes looks at the first nonsteroidal oral med for Duchenne muscular dystrophy, expanded indications for a cardiovascular risk reduction drug, an oncology approval, two Complete Response…
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…
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…
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…
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…
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.…
This edition of Quick Notes reviews four CHMP positive opinions, including a once-weekly insulin treatment for patients with type 2 diabetes, an oral monotherapy for patients with a rare blood…
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…
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…