FDA publishes a guidance to assist applicants in incorporating heart rate-corrected (QTc) interval of prolongation-related information in the labeling...
A Washington, DC, federal judge rules that FDA acted unlawfully when it denied a priority review voucher to Sun Pharma and its drug Sezaby, the first ...
Weeks into his new appointment, CDER director Richard Pazdur files paperwork to retire by the end of the month.
FDA issues an early alert concerning certain Abbott Diabetes Care glucose monitor sensors, warning patients and healthcare providers about potentially...
Government prosecutors win guilty conviction against Hi-Tech Pharmaceuticals CEO and twice-convicted felon Jared Wheat for orchestrating a years-long ...
The House approves legislation reauthorizing the FDA Pediatric Rare Disease Priority Review Voucher program and giving the agency the authority to ord...
FDA publishes a draft guidance on streamlined nonclinical safety studies for monoclonal antibodies.
FDA issues a safety alert after Becton Dickinson recently recalled (Class 1 device correction) certain Alaris Pump Modules if they have been dropped o...
