FDA Updating Electronic Nonclinical Study Data Submission Formats

August 25, 2017

The FDA has officially announced it is transitioning to an updated version of its format for submitting nonclinical study data in support of drug approvals.

The 3.1 version of the format, known as SEND IG, has been available from CDSC since July 2016. The FDA is encouraging applicants to use SEND IG 3.1 now for their data submissions.

SEND IG 3.1 will be required for electronic submissions from studies that start after March 15, 2019. Support for SEND IG 3.0 will end that day for those studies.

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