Federal Register notice: FDA makes available a draft guidance entitled Incorporating Voluntary Patient Preference Information over the Total Product L...
Federal Register notice: FDA announces a 10/10 Cardiovascular and Renal Drugs Advisory Committee meeting to review a Stealth BioTherapeutics NDA for e...
GSK says data from its Phase 3 MATINEE clinical trial evaluating chronic obstructive pulmonary disease drug Nucala (mepolizumab) met its primary endpo...
FDA clears an Odin Medical (an Olympus subsidiary) 510(k) for what it describes as the first cloud-based artificial intelligence technology to assist ...
FDA issues Regenerative Processing Plant a Warning Letter based on a 2023 inspection of the firms Palm Harbor, FL, manufacturing plant that found sign...
An April inspection of Japans Taenaka Kogyo ends in a four-observation Form FDA-483 that cites significant GMP violations.
FDA posts a Form FDA-483 issued to Biocon Biologics at the end of a July inspection at the firms Bengaluru, India manufacturing facility.
FDA publishes a draft guidance on incorporating voluntary patient preference information in medical device total life cycle regulatory decisions.
