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While Apple’s request earlier this week for an interim stay of federal orders to stop selling its watches is hardly an emergency, according to Masimo, a federal court has agreed to Apple’s request and issued a temporary stay on the ban. Read More
As 2023 draws to a close, the FDA has issued several final guidances, including documents on collecting trial data with digital health technologies, developing rare disease drugs and biologics, and complying with a final rule on TV and radio prescription drug ads, as well as a new draft guidance on clinical trial master protocols. Read More
The FDA delivered a couple of unwelcome holiday gifts to two hopeful sponsors in the form of Complete Response Letters (CRL) — one for Merck’s chronic cough drug gefapixant and the second for Zealand Pharma’s dasiglucagon, an investigational agent intended to treat congenital hyperinsulinism. Read More
As if lawsuits and plummeting stock prices from its faulty CPAP machines didn’t provide enough bad headlines, Philips now wants customers to pull the plug on one of its magnetic resonance imaging machines due to the potential for an explosion. Read More
Bristol Myers Squibb’s (BMS) $14 billion acquisition of Karuna Therapeutics accelerates the company’s diversification into the neuroscience space with Karuna’s priority asset, KarXT (xanomeline-trospium), leading the way. Read More
Ultragenyx Pharmaceutical has agreed to pay $6 million to resolve allegations that it caused the submission of false claims to Medicare and Medicaid, according to the Department of Justice (DOJ). Read More
CDER has developed a new adaptive crossover trial design that can be used in demonstrating the bioequivalence (BE) of generic versions of drugs with high pharmacokinetic (PK) variability. Read More
A newly published Q&A document from the FDA and the European Medicines Agency (EMA) outlines the similarities — and differences — in the two agencies’ requirements for manufacturing breakthrough products. Read More
The FDA has smacked Fresenius Kabi with a warning letter for selling adulterated devices that fail to conform to current good manufacturing practice (cGMP) requirements, following an inspection of the devicemaker’s Waltham, Mass., facility from June 26 to Aug. 2. Read More
A recently approved position paper from the European Association of Medical Devices Notified Bodies — referred to as Team-NB — addresses the question “What should ‘lifetime’ mean in guidelines when referring to the lifespan of medical devices?” Read More
In this edition of Quick Notes, we look at FDA breakthrough designation for a pulsed ablation system for treatment of atrial fibrillation, an implant to treat glaucoma and ocular hypertension, a label expansion for a game-based digital therapeutic device for adolescents with ADHD, and an antigen test to detect the presence of a cancer-causing bacteria. Read More