Standardized study data will be required in commercial IND application submissions for clinical and nonclinical studies that start on or after December 17, 2017. On CDER's website you can find Study Data Standards Resources that provides specifications for sponsors regarding implementation and submission of clinical and nonclinical study data in standardized format.
CDER Standardized Study Data
The Electronic Common Technical Document (eCTD) is CDER and CBER's standard format for electronic regulatory submissions. Beginning May 5, 2017, the following submission types: NDA, ANDA, BLA, and Master Files must be submitted in eCTD format. Commercial IND submissions must be submitted in eCTD format beginning May 5, 2018. Submissions that do not adhere to the requirements stated in the eCTD guidance will be subject to rejection.
John Van Hoven, MS
I started this blog to document my thoughts on working in the medical product regulatory field, in particular my experiences working with the FDA. I hope you find it somewhat helpful.