[ Price : $8.95]
FDA undertakes a broad modernization of its inspection program, including expanded use of risk-based oversight, greater reliance o...[ Price : $8.95]
FDA issues an updated final guidance entitled Applying Human Factors and Usability Engineering to Medical Devices.[ Price : $8.95]
FDA grants Eli Lilly a breakthrough therapy designation for olomorasib as a monotherapy for treating adult patients with advanced ...[ Price : $8.95]
Sandoz reaches agreements totaling about $479 million to resolve most of its remaining exposure in long-running U.S. litigation al...[ Price : $8.95]
FDA regulatory experts support the agency's new "Operation Trialblazer" initiative as an important step toward accelerating drug d...[ Price : $8.95]
FDA cites Australian manufacturer Veganic SKN Limited for multiple current good manufacturing practice deficiencies following a 7/...[ Price : $8.95]
A new FDA draft guidance outlines how sponsors should develop and evaluate container closure systems and device components used wi...[ Price : $8.95]
A new Harvard Law School legal commentary argues that decades of policies designed to accelerate pharmaceutical innovation may hav...