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Agency adheres to 45-day review timelines, guarantees response letters

FDA Finalizes Guide On Special Protocol Assessment Pacts With Drug Makers

April 16, 2018
FDA on Friday (April 13) issued a final guidance on special protocol assessment (SPA) agreements with drug manufacturers that rejects industry's call for a shorter review time, promises more transparency and clarifies that SPAs don't apply to devices. The guidance outlines how drug sponsors should go about arranging meetings with FDA and how the agency will handle rescinding or accepting SPA agreements, which allow FDA and sponsors to communicate about the size and design of certain clinical trials, clinical studies...


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