FDA commissioner Robert Califf posts a positive report on his recent visit to India and the work he says that the countrys government and drug industr...
FDA releases the form FDA-483 with four observations from an inspection at Switzerlands UCB Farchim drug manufacturing facility.
Hyman, Phelps & McNamara attorney Dara Levy says FDA is taking a new approach to off-label presentations in a new draft guidance.
ResMed Ltd. recalls its Astral 100 and Astral 150 ventilators due to what FDA calls a device design issue.
FDA accepts for review an AstraZeneca supplemental BLA that seeks approval for a self- or caregiver-administered option for FluMist Quadrivalent, a ne...
Federal Register notice: FDA seeks comments on an information collection extension entitled Export Certificates for FDA Regulated Products.
Federal Register notice: FDA posts a revised draft guidance for industry entitled Communications From Firms to Health Care Providers Regarding Scienti...
FDA and two international regulatory partners state five guiding principles for predetermined change control plans in machine learning-enabled medical...
