Former CDRH Division of Cardiovascular, Respiratory, and Neurological Devices acting deputy director Daniel Spyker joins NDA Partners as an expert con...
TrapX says its cybersecurity investigators have found malware on medical devices in a variety of venues.
CDERs Richard Pazdur and Gideon Blumenthal talk about oncology drug approvals in 2016 and what the future will likely bring.
FDA accepts for priority review an NDA from the Medicines Co. for Carbavance (meropenem-vaborbactam) for treating complicated urinary tract infections...
The Trump Administration plans to submit its budget plan to Congress on 3/14.
Molecular diagnostic company Immunexpress receives 510(k) clearance for the use of SeptiCyte LAB as an aid in differentiating infection-positive (seps...
FDA awards contract research organization ICON a contract to validate three patient reported outcomes instruments that will measure clinical endpoints...
AdvaMed tells FDA its priorities for medical device guidances the agency hopes to issue this fiscal year.