FDA investigators issue a 24-page Form FDA-483 citing numerous manufacturing violations after a 12-day inspection in May of Apotexs sterile drug facil...
CDCs Advisory Committee on Immunization Practices votes to discontinue the longstanding policy that all newborns receive the Hepatitis B vaccine withi...
An FDA advisory committee votes unanimously against recommending approval of Johnson & Johnsons V-Wave heart shunt for patients with advanced heart fa...
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...
