FDA undertakes a broad modernization of its inspection program, including expanded use of risk-based oversight, greater reliance on remote evaluation ...
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 anticompetiti...
FDA cites Australian manufacturer Veganic SKN Limited for multiple current good manufacturing practice deficiencies following a 7/2025 inspection of i...
A new FDA draft guidance outlines how sponsors should develop and evaluate container closure systems and device components used with biosimilar and in...
A new Harvard Law School legal commentary argues that decades of policies designed to accelerate pharmaceutical innovation may have instead encouraged...
FDA finalizes a guidance outlining how generic drug developers should evaluate the adhesion performance of transdermal and topical delivery systems.
