FDA Testing Data Exchange Standards For Drug Specifications Under PQ/CMC Pilot
Executive Summary
FDA announces the rollout of a pilot program with industry to exchange data on quality specifications for the Common Technical Document’s Module 3. The agency plans to exchange data on other portions of the CTD’s quality section later this year. The data exchange would largely replace the “hunting and pecking” for information in PDFs that reviewers have to do to locate quality information in NDAs and ANDAs.
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