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FDA says Baxter International has issued an urgent medical device correction for its WatchCare incontinence system that may cause ...[ Price : $8.95]
FDA publishes a guidance to help agency staff request additional information needed to make decisions on medical device marketing ...[ Price : $8.95]
The Medical Device Innovation Consortium releases its first medical device manufacturer benchmark report on cybersecurity maturity...[ Price : $8.95]
FDA commissioner Robert Califf says he hopes Congress will include regulation of laboratory-developed tests and several other issu...[ Price : $8.95]
FDA postpones an 11/18 joint advisory committee that was going to vote on a Laboratoire HRA Pharma supplemental NDA for Opill (nor...[ Price : $8.95]
FDA accepts for priority review a Seres Therapeutics BLA for its investigational oral microbiome therapeutic SER-109 for preventin...[ Price : $8.95]
Federal Register notice: FDA announces an 11/17 public workshop entitled Quantitative Brain Amyloid PET Imaging in Patients with A...[ Price : $8.95]
The International Council for Harmonization posts a presentation outlining its finalized guidance entitled A Selective Approach to...