top of page

Guidance on Providing Regulatory Submission in e-Format for Standardized Study Data -US FDA

This guidance and the technical specifications document it incorporates by reference describe the requirements for electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the FD&C Act.

In accordance with section 745A(a), following the issuance of final guidance on this topic, study data contained in the submission types identified in this guidance must be submitted electronically in a format that 18 FDA can process, review, and archive.

This guidance implements the electronic submission requirements of section 745A(a) of the FD&C Act for study data contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and Investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) by specifying the format for electronic submissions.

This is the finalized guidance released by FDA on 22-June-2021

8 views0 comments


bottom of page