The European Medicines Agency (EMA) has released a document detailing how the agency’s real-world evidence (RWE) office can help with medical research. Source: Drug Industry Daily

Fake Botox has sent nine people to the hospital and caused harmful reactions in 10 others, prompting an FDA investigation and a warning about counterfeit forms of the neurotoxin from…

Marketing its cardiac device — intended to treat chronic angina — for un-cleared uses such as growth of new arteries, reduction of COVID-19 symptoms, regeneration of pancreatic tissue, and hair…

The Pharmacy Care Management Association (PCMA), a national association representing pharmacy benefit managers, opposes state laws requiring PBMs to act in the best interests of health plans they serve, saying…

CDRH has unveiled a new dataset to help improve chemical characterization methods for biocompatibility of medical devices as part of its efforts to reduce the burden of premarket processes and…

Three Eugia Pharma plants in India have received Form 483s following inspections conducted in the last two months, all laden with examples of the company failing to follow procedures to…

The Abbott/Thoratec recall of HeartMate II and HeartMate 3 left ventricular assist system (LVAS) has been deemed Class I, the most serious type of recall, by the FDA. Source: Drug…

Of the $341 million increase in funding requested for the FDA in President Biden’s FY 2025 budget proposal, $114 million is needed to fund FDA employees’ 5 percent inflation pay…

A new CDER sub-center is looking for drug developers with specific in-process studies for a demonstration program intended to boost innovation in clinical trial design. Source: Drug Industry Daily

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…