FDA publishes a guidance on implementing the eCopy submission program for medical devices.
FDA launches a pilot with the Center for Medicare and Medicaid Innovation to promote access to certain digital health devices covered through a new Ce...
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.
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.
