CDER launches its Drug Risk Management Board to facilitate rapid analysis and resolution of drug safety issues throughout the Center.
FDA publishes a guidance on computer-assisted detection devices applied to radiology images and radiology device data.
FDA releases its latest batch of Warning Letters that includes CGA Limited, Curewave Lasers, Tismor Health and Wellness, Vevazz and Zhuhai Aofute Medi...
FDA approves a Horizon Therapeutics BLA for Tepezza (teprotumumab-trbw) for treating adults with thyroid eye disease.
A Government Accountability Office report describes six policy options for overcoming challenges to increasing the use of machine learning in drug dev...
CDER says names of the Office of New Drugs offices and divisions were changed as part of its reorganization.
FDA warns Australias Tismor Health and Wellness about CGMP and other violations in its work as a contract manufacturer of finished drugs.
Federal Register notice: FDA seeks comments on an information collection extension for Radioactive Drug Research Committees21 CFR 361.1.