FDA grants Vitestro a de novo authorization for Aletta, the first standalone robotic device designed to draw blood from a patients arm without hands-o...
FDA accepts for review a Teva Pharmaceuticals NDA for ecopipam, indicated for treating pediatric patients with Tourette syndrome.
FDA warns Indias Eugia Pharma about CGMP violations at its drug manufacturing facility in Kolthur Village.
President Donald Trump selects White House health policy adviser Heidi Overton as his nominee to become FDA commissioner.
FDA cites Neeyaan LLC for multiple GMP deficiencies, including the firms failure to validate drug manufacturing processes, conduct cleaning validation...
Mosaic Clinical Technologies petitions FDA to explain the regulatory principles it is applying to artificial intelligence vision language models.
FDA asks for stakeholder responses to six discussion questions in a paper on regulating generative AI-enabled medical devices.
FDA warns Chinas Tianjin Kilo Pharmaceutical Sci-tech Co. about CGMP deviations the agency found in records it requested on the companys manufacturing...
