FDA undertakes a broad modernization of its inspection program, including expanded use of risk-based oversight, greater reliance on remote evaluation tools, and a sharp increase in unannounced inspections of foreign manufacturing facilities.
FDA issues an updated final guidance entitled “Applying Human Factors and Usability Engineering to Medical Devices.”
FDA undertakes a broad modernization of its inspection program, including expanded use of risk-based oversight, greater reliance on remote evaluation tools, and a sharp increase in unannounced inspections of foreign manufacturing facilities.
FDA issues an updated final guidance entitled “Applying Human Factors and Usability Engineering to Medical Devices.”
FDA grants Eli Lilly a breakthrough therapy designation for olomorasib as a monotherapy for treating adult patients with advanced pancreatic cancer.
Sandoz reaches agreements totaling about $479 million to resolve most of its remaining exposure in long-running U.S. litigation alleging anticompetitive pricing practices in the generic drug market.
