The FDA FY 2021 GDUFA Science and Research Outcomes Report demonstrates how GDUFA research projects have contributed to the development of generic dru...
FDA says it is partnering with the Critical Path Institute to explore creating a Lysosomal Diseases Consortium as part of the Accelerating Rare Diseas...
FDA clears an eCential Robotics 510(k) for its 3D imaging, navigation and robotics guidance system for use in bone surgical procedures.
As it negotiates a consent decree over its ventilators and other airway devices with the Department of Justice (DoJ), the company agrees to settle Fal...
FDA says the Integra recall of 388 CereLink intracranial pressure monitors is Class 1.
Federal Register notice: FDA announces a 10/28 Oncologic Drugs Advisory Committee meeting.
Federal Register notice: FDA announces a 10/20 advisory committee meeting that will vote on a SolvD test to identify opioid use disorder at-risk patie...
FDA officials say the agency is taking a whole-of-governments approach to combating the entry of illicit healthcare products into the U.S.
