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...
Federal Register notice: FDA sends to OMB an information collection extension for Generic Clearance for the Collection of Qualitative Feedback on Agen...
Federal Register notice: FDA sends to OMB an information collection extension for Exceptions or Alternatives to Labeling Requirements for Products Hel...