CBER director Vinay Prasad addresses a 12/4 investor conference in New York and defends his leadership, and attributing criticism to "misleading media...
CDER Office of Compliance director Jill Furman highlights a year of sweeping operational shifts, heightened enforcement, and emerging use of artificia...
FDA commissioner Marty Makary alleges that the Biden administration failed to disclose internal data on myocarditis risks in young people following Co...
FDA solicits proposals for the CDER Center for Clinical Trial Innovation Bayesian Statistical Analysis demonstration project.
CBER says that a common deficiency that is driving a significant share of BLA-related complete response letters is manufacturing facility inspection r...
FDA lifts a partial clinical hold on one of Vanda Pharmaceuticals key tradipitant studies, clearing the company to expand dosing in an ongoing motion-...
FDA issues a device correction alert after Olympus recalled (Class 1) the instructions for its Single Use Ligating Device PolyLoop, warning that impro...
provals managing director Steven Cohen lists the many benefits of FDA advisory committees even as the agency has reduced its use of them significantly...
