Five stakeholders respond to FDA docket questions about expanding home medical technology use.
FDA approves a five-year $50 million contract renewal with the University of Maryland Center of Excellence in Regulatory Science and Innovation.
FDA clears an Aion Biosystems 510 (k) for its iTempShield device and software system for continuous measurement of body temperature.
Abeona Therapeutics plans to file a BLA for EB-101, a cell therapy for patients with recessive dystrophic epidermolysis bullosa, after a pre-BLA meeti...
FDA grants Quest Diagnostics a breakthrough device designation for its AAVrh74 ELISA assay for identifying Duchenne muscular dystrophy patients eligib...
Reagan-Udall Foundation director of research Carla Rodriguez explains the RAISE program that is helping to collect, curate, and integrate race and eth...
FDA warns Pomona, CA-based K.C. Pharmaceuticals about CGMP violations in its production of finished drugs.
FDA warns Miami, FL-based Gadal Laboratories about CGMP violations in its production of finished drugs.