A CDER Spotlight on Science describes how the Office of Pharmaceutical Quality is researching the effects of mitochondrial drugs on cancer cells.
Federal Register notice: FDAs Oncology Center of Excellence Pediatric Oncology Program has announced the creation of two lists of molecular targets fo...
CDERs Office of Prescription Drug Promotion cautions Eisai about a sales representatives misleading presentation on the safety of its Fycompa.
Federal Register notice: FDA classifies the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel into Class 2 (special controls).
Federal Register notice: FDA determines the patent extension-related regulatory review period for Janssen Biotechs Tremfya (guselkumab), indicated for...
Federal Register notice: FDA debars Isachi Gil for six years from providing services in any capacity to a person that has an approved or pending drug ...
FDA solicits comments on two proposed CDER Office of Prescription Drug Promotion research projects.
FDA chief of staff Lauren Silvis says the agency is evolving to keep pace with technology advances, and one area it wants to focus on is product label...