Medical device regulation expert Adrienne Lentz describes the highlights from a 4/2 FDA Quality Management System Regulation town hall.
FDA posts a draft guidance outlining how drug developers should evaluate the safety of human gene therapies that use genome editing.
Exelixis petitions FDA to require Handa Pharmaceuticals and others submitting a 505(b)(2) NDA for a caboztinib product referencing Exelixis Cabometyx ...
Three McDermott attorneys outline the key elements in an FDA 3/2026 guidance that helps establishments respond to an FDA-483.
FDA has issued a reminder to more than 2,200 clinical trial sponsors and researchers, urging them to comply with federal requirements to publicly repo...
A panel of industry leaders, policy experts, and FDA say broader adoption of external control arms in oncology drug development will depend on improve...
FDA cites an Indian drug manufacturer for deficiencies in laboratory testing and quality control procedures following an inspection conducted in Decem...
FDA is reportedly considering ophthalmologist and biotech executive Houman Hemmati as CBERs next director.
