[ Price : $8.95]
FDA publishes the International Council on Harmonization E11A Pediatric Extrapolation guidance.[ Price : $8.95]
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]
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.[ Price : $8.95]
CDER updates its CDER NextGen Portal to allow Right to Try annual summary submissions for CDER-regulated products.[ Price : $8.95]
FDA posts a final guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic...[ Price : $8.95]
FDA encourages drug sponsors to use centralized statistical monitoring to help keep an eye on clinical trial integrity issues.