The CDER Office of Surveillance and Epidemiology 2022 annual report highlights activities in public health emergencies, drug risk assessment, and drug...
Oncology Center of Excellence director Richard Pazdur explains what FDA can and cant do to address cancer drug shortages.
Federal Register notice: FDA intends to inactivate the registration of establishments that manufacture human cells, tissues, or cellular or tissue-bas...
FDA proposes a regulation to replace the current Medication Guides with a one-page Patient Medication Information sheet.
FDA warns Woburn, MA-based Advanced Compounding Solutions about multiple violations in its production of unapproved and misbranded compounded drugs.
FDA accepts for priority review a Bristol Myers Squibb NDA for repotrectinib and its use for treating patients with ROS1-positive locally advanced or ...
FDA approves Blue Earth Diagnostics Posluma (flotufolastat F 18) injection, a prostate-specific membrane antigen-targeted positron emission tomography...
A developer of drugs to treat neovascular age-related macular degeneration raises issues with an FDA draft guidance on developing drugs for the condit...
