CBER says that a common deficiency that is driving a significant share of BLA-related complete response letters is manufacturing facility inspection r...
FDA commissioner Marty Makary alleges that the Biden administration failed to disclose internal data on myocarditis risks in young people following Co...
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 reportedly is exploring ways PDUFA fees can be adjusted to incentivize companies to hold clinical trials in the U.S. rather than overseas.
The Sedgwick third-quarter recall index sees a sharp increase in the number of affected drug and medical device units.
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 publishes a guidance on implementing the eCopy submission program for medical devices.
