New research uncovers numerous software vulnerabilities in medical devices.
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide product-specific recommendatio...
Federal Register notice: FDA sends to OMB an information collection extension entitled MedWatch: The FDA Medical Products Reporting Program.
The House Oversight and Reform Committee requests information on FDAs consulting contracts with McKinsey due to potential conflicts with consulting co...
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug and abbreviated new animal ...
FDA acting commissioner Janet Woodcock says there continues to be huge opportunities for growth in the generic and biosimilar space.
FDA approves an Eton Pharmaceuticals and Azurity Pharmaceuticals NDA for Eprontia (topiramate) oral solution, 25mg/mL, indicated as a monotherapy for ...
FDA clears a Magstim 510(k) for the Horizon 3.0, a transcranial magnetic stimulation device designed for the clinical setting.