Project Scope Nonclinical ts.xpt files that are typically created and submitted to the FDA. Problem Statement
Problem Impact With this project, PHUSE will enable industry to evaluate the factors leading to acceptance/rejection and to confidently produce TS files that have been shown to avoid rejections once the TRC go into effect, if the project is launched quickly and delivers soon enough. |
Project Leads | |
Michael DeNieu | michael.deNieu@covance.com |
William Houser | william.houser@bms.com |
Paula Rowley (PHUSE Project Assistant) | paula@phuse.global |
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Project concluded, see final deliverables below. |
Resources |
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How to open the files to review in eCTD Folder Structure Testing Simplified TS Examples Against FDA Technical Rejection Criteria Webinar |
Objectives & Deliverables | Timelines |
This project must publish its conclusions in time for industry to be prepared for the implementation of the TRC, which is planned for September 15. If industry needs two months to act, this project plans to complete the following by July 15:
| A detailed timeline will follow shortly with a target end date of September 2021. |