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…
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…
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…
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. Source: Drug Industry…
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).…
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. Source: Drug…
The FDA may allow third-party 510(k) reviews for Emergency Use Authorization (EUA) requests, according to a new draft guidance. Source: Drug Industry Daily
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.…
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…
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…