FDA tells NDA and ANDA sponsors they must repeat clinical and bioanalytical studies conducted for their applications by Synapse Labs in Pune, India, d...
Six stakeholders express appreciation for and suggest improvements to an FDA draft guidance on using real-world evidence in non-interventional studies...
Federal Register notice: FDA issues a final rule revising its requirements for current good manufacturing practice, postmarketing safety reporting, an...
FDA places a partial clinical hold on three Zentalis Pharmaceuticals azenosertib studies after two recent deaths due to presumed sepsis were reported....
FDA grants Elixir Medical a Breakthrough Device Designation for its novel bioadaptive implant DynamX Sirolimus-Eluting Coronary Bioadaptor System for ...
FDA grants Merck accelerated approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine) for preventing invasive disease and pneumonia caused by...
FDA clears an Akili 510(k) for EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder.
FDA publishes its report on an 11/2023 workshop on increasing clinical trial diversity.
