FDA commissioner Scott Gottlieb says the agency is seeking international harmonization of generic drug scientific and technical requirements as a way ...
Five stakeholders respond to an FDA draft guidance on use of expansion cohorts in some oncology trials.
FDA and the Department of Homeland Security sign a Memorandum of Understanding on medical device cybersecurity coordination.
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...