Wisconsin cardiologist Nalini Rajamannan contacts FDA commissioner Stephen Hahn over the agencys decision not to provide information to patients who w...
Federal Register notice: FDA seeks comments on an information collection extension for Reporting Associated With Animal Drug and Animal Generic Drug U...
Federal Register notice: FDA seeks comments on an information collection extension for Electronic Products 21 CFR Parts 1000 Through 1050.
Federal Register notice: FDA determines that Chiesi USAs Cardene (nicardipine hydrochloride) injection, 25 mg/10 ml, was not withdrawn from sale for s...
FDA publishes a guidance on changes in the Biosimilar User Fee program.
FDA highlights potential cybersecurity vulnerabilities in some GE Healthcare Clinical Information Central Stations and Telemetry Servers.
Federal Register notice: FDA classifies radiological computer-aided triage and notification software into Class 2 (special controls).
Federal Register notice: FDA classifies the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer into Class 2 (...