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Some Advisory Committee Patient Reps Have Conflicts: Study
An analysis by two University of Southern California policy researchers finds that between 2013 and 2022, some 38% of FDA advisory committees included either a patient or consumer representative with active ties to an advocacy organization funded by a drug company. Writing in an open-source article for Project Hope,
Former FDA Official Questions Agency Role in Drug Pricing
Former FDA regulatory counsel and now-partner at Spencer Fane Brian Malkin is questioning whether the agency should become more directly involved in the Trump administration's drug-pricing initiatives, raising concerns about the potential direction of FDA policy under commissioner nominee Heidi Overton, whose nomination remains pending in
FDA Uses Machine Learning to Identify Opioid CV Signals
FDA researchers and academic collaborators identified nearly 80,000 prescription opioid-related cardiovascular adverse event signals in a large-scale analysis of the agency's Adverse Event Reporting System, suggesting that machine learning could improve postmarketing drug safety surveillance. The study, published September 28 in Frontiers in Drug Safety
CGMP Violations Seen in Eurofins Labs Inspection
A 6/1-6/3 FDA inspection at the Eurofins SF Analytical Laboratories drug manufacturing facility in Horsham, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/6 Warning Letter says the three specific violations were: * failure to ensure that laboratory