TS XPT Generator
On September 15th 2021, new study data technical rejection criteria will be applied to eCTD sequences submitted to FDA via the Electronic Submission Gateway (ESG).
From this point on, FDA will not accept an electronic submission that does not have nonclinical and clinical study data in compliance with the required standards specified in the FDA Data Standards Catalog.
The study data standards apply to the following types of submissions sent to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER):
- Existing and new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and all subsequent submissions to these types of applications, including amendments, supplements
- Commercial investigational new drug applications (INDs) (for products that are intended to be distributed commercially)
The amount of information provided and understanding what’s required may appear overwhelming; however, help is available. The agency has provided an “FDA Study Data Prep – Self Checklist” and provides a vast amount of information on their website “Study Data for Submission to CDER and CBER”. However, this is only a first step towards a compliant and effective data preparation process.
PharmaLex offers a free tool to generate simplified ts.xpt files
With PharmaLex’ long-lasting experience with electronic submissions of Study Data to FDA, our consultants will help you with your transformation. When September rolls around the corner, you will be prepared and ready with your data to ensure successful submissions and celebratory application approvals.
Disclaimer: Please note that the free functionality of this tool comes with no warranty that the output file is technically/formally correct.