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FDA publishes Annex 2 of the International Council on Harmonization Good Clinical Practice guidance.[ Price : $8.95]
FDA warns a Canadian Brands International facility about limiting and delaying an inspection that also identified CGMP violations.[ Price : $8.95]
CDER senior advisor for clinical science Bob Temple retires, and FDA principal deputy commissioner Namandj Bumpus leaves the agenc...[ Price : $8.95]
Xbrane Biopharma refiles a BLA for its investigational ranibizumab, a biosimilar copy of Genentechs age-related macular degenerati...[ Price : $8.95]
FDA issues a safety alert on Nuwellis AquaFlexFlow UF 500 Plus extracorporeal blood circuit because the device may trigger a weigh...[ Price : $8.95]
Four senators introduce bipartisan legislation to protect generic drug manufacturers from innovator drug lawsuits over skinny labe...[ Price : $8.95]
FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Thursday, Jan 2, 2025.[ Price : $8.95]
FDA clears a Zimmer Biomet 510(k) for the OsseoFit Stemless Shoulder System for total shoulder replacement.