Four stakeholders praise an FDA draft guidance on streamlining some oncology nonclinical safety studies and recommend improvements to the draft.
FDA cites Australian manufacturer Veganic SKN Limited for multiple current good manufacturing practice deficiencies following a 7/2025 inspection of i...
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 finalizes a guidance outlining how generic drug developers should evaluate the adhesion performance of transdermal and topical delivery systems.
