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 regulatory experts support the agency's new "Operation Trialblazer" initiative as an important step toward accelerating drug development but cauti...
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A new FDA draft guidance outlines how sponsors should develop and evaluate container closure systems and device components used with biosimilar and in...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...
