Shadow FDA? Researchers Are Taking Approval Matters into their Own Hands
Drug and biotech companies will face an emerging trend of outside interference on pending drug reviews at FDA. The events surrounding the final outcome of FDA's review of Bristol-Myers Squibb and Merck's diabetes drug muraglitazar (Pargluva) signal that outside medical centers and prominent researchers will voluntarily play a larger role in drug safety oversight in the future.
By Ramsey Baghdadi
It was so close. FDA had finished its review of Bristol-Myers Squibb Co. /Merck & Co. Inc. 's...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on In Vivo for daily insights
Against a backdrop of shifting trade policies, the end of multilateral market approaches and renewed focus on supply chain resilience, medtechs are doubling down on innovation in products and processes – using AI – and keeping unmet needs and outcomes in the center of the target.
While biopharma companies experiment with genAI, agentic AI is rapidly shifting the work paradigm towards one of autonomous digital workers that can handle entire process flows.