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FDA revises the fact sheets on Janssens Covid-19 vaccine to include a warning about reported adverse events that suggest increased...[ Price : $8.95]
FDA clears a TytoCare 510(k) for its Tyto Insights for Wheeze Detection, an algorithm for use on the companys existing artificial ...[ Price : $8.95]
FDA warns Chatsworth, CA-based Formology Lab about CGMP violations in its production of drugs as a contract manufacturer.[ Price : $8.95]
FDA warns Houston, TX- based Dr. Maggie Jeffries/Avanti Anesthesiology about conducting a clinical investigation without a require...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance for industry entitled Evaluation of Gastric pH-Dependent Drug Intera...[ Price : $8.95]
Federal Register notice: FDA revokes the Emergency Use Authorizations for Covid-issued to Abbott Diagnostics and Standard BioTools...[ Price : $8.95]
FDA amends the emergency use authorization for the Pfizer-BioNTech Covid-19 bivalent vaccine and its use as a single booster dose ...[ Price : $8.95]
FDA warns Orlando, FL-based Profounda about CGMP violations in its production of finished drugs as a contract manufacturer.