[ Price : $8.95]
Medical device regulation expert Adrienne Lentz describes the highlights from a 4/2 FDA Quality Management System Regulation town ...[ Price : $8.95]
FDA posts a draft guidance outlining how drug developers should evaluate the safety of human gene therapies that use genome editin...[ Price : $8.95]
Exelixis petitions FDA to require Handa Pharmaceuticals and others submitting a 505(b)(2) NDA for a caboztinib product referencing...[ Price : $8.95]
Three McDermott attorneys outline the key elements in an FDA 3/2026 guidance that helps establishments respond to an FDA-483.[ Price : $8.95]
FDA has issued a reminder to more than 2,200 clinical trial sponsors and researchers, urging them to comply with federal requireme...[ Price : $8.95]
A panel of industry leaders, policy experts, and FDA say broader adoption of external control arms in oncology drug development wi...[ Price : $8.95]
FDA cites an Indian drug manufacturer for deficiencies in laboratory testing and quality control procedures following an inspectio...[ Price : $8.95]
FDA is reportedly considering ophthalmologist and biotech executive Houman Hemmati as CBERs next director.