Philips Respironics recalls its V60 and V60 Plus ventilators that provide High Flow Therapy, due to a risk to the patients if the system pressure reac...
Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Device Recall Authority--21 CFR Part 810.
Federal Register notice: FDA extends the comment period for a 6/4 notice about a draft guidance entitled Enhanced Drug Distribution Security at the Pa...
FDA warns Syntec Pharma about CGMP deviations in its production of active pharmaceutical ingredients.
FDA clears an Abbott 510(k) for its latest optical coherence tomography (OCT) imaging platform powered by the companys new Ultreon Software.
FDA lifts a partial clinical hold against a Novartis investigational gene therapy OAV-101 intrathecal clinical trial for spinal muscular atrophy.
A Senate appropriations subcommittee votes to advance FDAs fiscal year 2022 budget with a $200 million (6%) spending boost.
FDA clears a RealView Imaging 510(k) for its Holoscope-i holographic system for creating spatially accurate, three-dimensional interactive medical hol...