FDA: EU Data Rule Has Hindered U.S. Inspections, Clinical Trials

A European data law that went into effect in 2018 has hindered FDA’s ability to do in-person inspections and remote regulatory assessments and to review data remotely during the pandemic, and the agency is concerned the law will have even broader consequences for clinical trial data sharing, adverse event reporting and medical product applications, Heather Messick, regulatory counsel for FDA’s drug center, wrote Tuesday (Aug. 9). The United States and European Union are working on a new data agreement that...