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FDA guidance withdrawals

This article was originally published in The Tan Sheet

Executive Summary

FDA withdraws three industry guidances on electronic submissions for new drug applications and abbreviated new drug applications "because they are no longer consistent with more recent guidance and no longer reflect the agency preferred format for receiving electronic submissions," according to a Sept. 29 Federal Register notice. The old guidances on electronic submissions recommended documents such as NDA table of contents to be submitted in portable document file (PDF) form. The agency has since been working in conjunction with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and ICH has issued specifications for electronic common technical documents (e-CDT) for marketing applications, namely the NDA table of contents is submitted as an extensible markup language (XML) file. "The e-CDT format is preferred by FDA because it is more efficient than the other choices and consistent with FDA's technical capabilities" and also is ICH's preferred format, the agency states...

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