Abstract: On Nov 22nd, 2021, the R Consortium R Submissions Working Group successfully submitted an R-based test submission package through the FDA eCTD gateway. The submission package has been received by the FDA staff who were able to reproduce the numerical results.  This submission was an example submission package following eCTD specifications which include a proprietary R package, R scripts for analysis, R-based analysis data reviewer guide, and other required eCTD components.  To our knowledge, this is the first publicly available R-based, or open-source-language-based FDA submission to the eCTD gateway for CDER. We hope this submission package and our learnings can serve as a good reference for future R-based regulatory submissions.
Speaker: Ning Leng and Hye Soo Cho
Affiliation: Roche | FDA
Title: R pilot submissions to FDA
Abstract_Sanitzed: On Nov 22nd, 2021, the R Consortium R Submissions Working Group successfully submitted an R-based test submission package through the FDA eCTD gateway. The submission package has been received by the FDA staff who were able to reproduce the numerical results.  This submission was an example submission package following eCTD specifications which include a proprietary R package, R scripts for analysis, R-based analysis data reviewer guide, and other required eCTD components.  To our knowledge, this is the first publicly available R-based, or open-source-language-based FDA submission to the eCTD gateway for CDER. We hope this submission package and our learnings can serve as a good reference for future R-based regulatory submissions.