Two stakeholders raise concerns about an FDA discussion paper on guidelines for pulse oximeters that consider skin pigmentation, race, and ethnicity.
FDA commissioner Robert Califf says FDA needs to work within a community of organizations assessing and evaluating artificial intelligence adaptive to...
FDA clears DermaSensor's real-time, skin cancer evaluation system.
FDA extends the shelf life of Emergent BioSolutions newly manufactured Narcan (naloxone HCl) 4 mg nasal spray products from three years to four years....
FDA recommends that the Drug Enforcement Administration down-classify marijuana from Schedule 1 to Schedule 3 under the Controlled Substances Act.
FDA grants Nurix Therapeutics a fast track designation for NX-5948 for treating certain adult patients with relapsed or refractory chronic lymphocytic...
Federal Register notice: FDA revises an information collection entitled Premarket Notification for a New Dietary Ingredient (NDI) 21 CFR 190.6.
FDA warns San Diego, CA-based Dr. Joel Kaplan Inc. about multiple violations in its manufacturing and distribution of several devices intended to enha...
