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FDAs Oncologic Drugs Advisory Committee votes nine to one in favor of approving a Mesoblast BLA for Ryoncil (remestemcell-L) as a ...[ Price : $8.95]
FDA issues the first two guidances with performance criteria for two medical device types to support the safety and performance-ba...[ Price : $8.95]
CDER researchers discuss the regulatory approach to assessing clinical benefit with a focus on pain.[ Price : $8.95]
FDA explains why it believes USP should not include disregard limits/reporting thresholds in any monograph revisions.[ Price : $8.95]
FDA issues two FAQ documents on medical device importing and registration/listing during the Covid-19 pandemic.[ Price : $8.95]
FDA clears a RapidAI 510(k) for the Rapid LVO for detecting suspected large vessel occlusions.[ Price : $8.95]
FDA clears Deep Blue Medical Advances T-Line hernia mesh.[ Price : $8.95]
FDA accepts a Novartis supplemental BLA for a new self-administration option for Xolair (omalizumab).