Maquet Datascope recalls its CardioSave Hybrid Intra-aortic Balloon Pump due to a design issue that allows fluid (e.g., saline) to seep into the devic...
Federal Register notice: FDA publishes modifications to its list of standards the agency recognizes for use in premarket reviews (FDA Recognized Conse...
CDER director Janet Woodcock says that administrative responsibility for the formal dispute resolution program has moved from the Office of New Drugs ...
FDA commissioner Scott Gottlieb and deputy commissioner Anna Abram say an agency working group is developing a plan for FDA efforts to promote biotech...
The HHS inspector general says an audit shows that FDA correctly computed PDUFA rates paid by drug companies.
FDA clears a K2M Group Holdings 510(k) for its Ozark Cervical Plate Systems for anterior screw fixation to the cervical spine in patients with degener...
A CDRH Webinar reviews changes made to next generation sequencing guidances.
The Association for Accessible Medicines urges FDA to adopt a case-by-case approach in determining whether a 505(b(2) biologic should be deemed to be ...