Attorney Michelle Yeary says a Tennessee federal court dismissed many parts of a failure-to-warn case against Boehringer Ingelheim over injuries alleg...
FDA issues a draft guidance leveraging its experience in implementing the MDUFA 3 Dual 5120(k) and CLIA Waiver by Application pathway.
FDA warns South Koreas Dae Young Foods Company about CGMP and misbranding violations in its work as a contractor manufacturing finished pharmaceutical...
CDER Office of Surveillance and Epidemiology deputy director Robert Ball describes the ways in which the agencys Sentinel System is being used and can...
A Public Citizen analysis of 457 rulemakings withdrawn by the Trump administration finds that 26 were from FDA, the highest number of any HHS agency.
FDA posts a draft guidance on Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for...
Two Hyman, Phelps attorneys say FDA is helping generic drug applicants by starting to list patent submission dates in the Orange Book.
Federal Register notice: FDA makes available a guidance entitled Pediatric Information for X-ray Imaging Device Premarket Notifications.