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FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.[ Price : $8.95]
FDA says a Boston Scientific recall updating instructions for two cryoablation balloon catheters is Class 1.[ Price : $8.95]
FDA warns Akorn Formulations in Hyderabad, Telangana, India, about CGMP violations in its production of over-the-counter drugs for...[ 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.