Federal Register notice: FDA seeks comments on an information collection extension for Medical Devices; Device Tracking 21 CFR Part 821.
FDA medical reviewers give a generally positive assessment of Biogens aducanumab that is indicated to delay clinical decline in patients with Alzheime...
FDA releases an FDA-483 with five observations from an inspection at STAQ Pharma.
FDA and the generic drug industry each offer proposals to advance quicker ANDA approvals.
Researchers say there is a correlation between medical device company payments to doctors and the selection of defibrillator devices to be implanted.
Bristol Myers Squibb announces positive results from POETYK PSO-1, a pivotal Phase 3 trial evaluating deucravacitinib, a novel, oral, selective tyrosi...
FDA warns Cosmax USA about CGMP violations in its production of finished drugs.
An FDA Webinar listening session discusses the role and operations of the new Digital Health Center of Excellence.