FDA authorizes personal sound amplification products as over-the-counter hearing aids for some consumers.
FDA publishes an updated guidance on replacement reagent and instrument family policy for in vitro diagnostic devices.
FDA warns Northridge, CA-based Verde Cosmetic Labs about CGMP violations in its production of finished drugs.
The HHS Office of Inspector General says the National Institutes of Health failed to enforce federal requirements that clinical trial results be timel...
Attorney Douglas Farquhar says FDA speakers at a GMP conference indicated that domestic drug facility inspections are back at operational levels.
FDA warns Baltimore, MD-based Emergent BioSolutions about repeat CGMP violations in its manufacturing of finished drugs.
FDA publishes a regional implementation guide for an International Council on Harmonization document on electronic transmission of individual case saf...
FDA accepts for review a Roche supplemental BLA for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus cyclophosphamide, d...
