Three stakeholders raise concerns about an FDA draft guidance on technical considerations to show the reliability of emergency-use injectors.
CDERs Shanthi Vigneshwaran discusses the Centers years of work to make its voluminous data more useable.
Chengdu Ai Qin E-commerce Co. recalls its colored contact lenses after FDA notified the firm that they were distributed without agency clearance and m...
FDA sets a 7/21 virtual public meeting to hear comments on the GDUFA 3 reauthorization.
FDA warns Rapid Equine Solutions that it is providing adulterated and misbranded compounded animal drugs.
FDA clears a Ekso Bionics 501(k) for the EksoNR robotic exoskeleton for use with patients with acquired brain injury.
An FDA online paper explains how the agency is leveraging its international collaboration activities to help respond to the Covid-19 pandemic.
FDA approves a Medtronic PMA for the Percept PC Deep Brain Stimulation system for treating patients with neurologic disorders associated with Parkinso...