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FDA sees increase in SPAs

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The Center for Drug Evaluation and Research is predicting that it will receive roughly 364 special protocol assessment requests from 143 sponsors in 2008, while the Center for Biologics Evaluation and Research estimates that it will receive roughly 10 requests from eight sponsors, according to an Oct. 12 Federal Register notice. Over the last three years, FDA has seen an increase in submissions of special protocol assessments, which were introduced in 2002 to allow companies to reach agreements on trial design with FDA in advance of conducting the study. FDA is working on new procedures that will help streamline the application process and ensure better tracking...
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