Federal Register notice: FDA posts a draft guidance entitled Dosage and Administration Section of Labeling for Human Prescription Drug and Biological ...
Federal Register notice: FDA classifies digital therapy devices used to reduce sleep disturbance for psychiatric conditions into Class 2.
Medtronics Coviden unit recalls its Mahurkar 13.5Fr high-flow, dual lumen acute dialysis catheter based on a potential leaking condition within the hu...
FDA approves a Novo Nordisk label update for Rybelsus (semaglutide) tablets 7 mg or 14 mg for a first-line treatment option for adults with Type 2 dia...
Kambiz Youabian (Tarzana, CA) pleads guilty to a two-count information charging him with mail fraud and introducing misbranded medical devices into in...
Indias BQ Prime financial news platform discloses five observations from an FDA inspection at an Alembic Pharmaceuticals non-sterile drug manufacturin...
FDA vaccines advisory committee member Paul Offit says the U.S. should stop trying to prevent symptomatic Covid infections in healthy young people by ...
FDA publishes a guidance to help applicants prepare the Dosage and Administration section of labeling for prescription drug and biological products.
