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FDA Testing Data Exchange Standards For Drug Specifications Under PQ/CMC Pilot

 
• By Joanne S. Eglovitch

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.

Data Transfer

FDA is launching a pilot in June to test the use of a standard data exchange program with industry for the quality portion of the Common Technical Document, called Module 3. The pilot will first test the exchange of data on drug specifications and then move to other areas of the CTD later this year.

This initiative is expected to free agency reviewers from hunting and pecking though PDF documents to find the data they need when reviewing the quality sections of new

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