The U.S. District Court for the District of Columbia rejected the FDA's attempt to classify Prevor's Diphoterine Skin Wash as a drug rather than a device for the second time, dealing industry a victory in the sometimes contentious arena of product classification decisions.
The FDA has put off reconsideration of Impax Laboratories' Parkinson drug Rytary. The delay will give the California company some additional time to work on the latest in a series of FDA concerns over its manufacturing that have kept the drug sidelined.
About three months before Hospira closed on its acquisition of an API plant from India's Orchid Chemicals & Pharmaceuticals, FDA inspectors made a visit to the facility in Waluj. They had concerns with what they found.
Tucked away in the Federal Register are the FDA's intentions to test its own labeling format to "inform FDA's planned regulatory approach to standardizing medical device labeling across the United States."
NPS Pharmaceuticals walked away from an FDA panel meeting with a recommendation to approve its orphan drug, but a lukewarm reception and nagging safety concerns have investors fearing the worst.
Observers tipped the arrival of Apple's long-awaited Watch to bring the worlds of health and tech closer than ever, but this week's announcement was notably light on medical uses. The failure to even mention HealthKit in the presentation has sparked discussion of Silicon Valley's wariness of healthcare regulators in the wake of 23andMe's run-in with the FDA.
The FDA has picked a successor to Howard Sklamberg to oversee the Office of Compliance (OC), Regulatory Focus reports.
For nearly two years, the FDA and a Texas compounder have been sparring over whether its products are safe and whether it will bend to the pressure the agency is exerting. The FDA sent a warning on Tuesday saying that the company cannot affirm its products are safe and that providers were taking a chance by using them.
Startup Tryton Medical has raised $20 million in venture capital to submit its side branch stent to the FDA and market it in Europe. It hopes to have the first coronary stent approved to treat bifurcation lesions in the U.S. Nearly one-third of patients undergoing coronary angioplasty have bifurcation lesions, according to the company.
The FDA has given clearance to startup Otoharmonics for its iPad and iPod Touch application that uses sound therapy to teach the brain to ignore persistent ringing caused by tinnitus.