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    FDA Revises Guidance on Special Protocol Assessments

    The draft guidance on the special protocol assessment (SPA) process is an update on guidance from 2002 and delves into the meetings between pharmaceutical or biotech sponsors and the US Food and Drug Administration (FDA) to discuss plans for clinical trials. Under the hopes that the SPA process will improve the quality of clinical trials, FDA has made significant changes from 2002 guidance, including: Clarification on which protocols are eligible for SPA; The addit...