FDA: Providing Regulatory Submissions in Electronic Format — Standardized Study Data – Draft Guidance (This guidance document is being distributed for comment purposes only)

This is one in a series of guidance documents intended to assist sponsors and applicants making regulatory submissions to FDA in electronic format. This guidance establishes FDA’s recommendation that sponsors and applicants submit study data in a standardized electronic format. This guidance applies to submissions of clinical and nonclinical study data within investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), investigational device exemptions (IDEs), biologics license applications (BLAs), premarketing notifications (510(k)s), and premarketing approval applications (PMAs), including original submissions, amendments, and supplements, to the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and  Research (CBER), and the Center for Devices and Radiological Health (CDRH). The purpose of this guidance is to promote the use of data standards in the electronic submission of study data to the FDA. We recognize that the use of data standards is complex and this guidance, by itself, is insufficient to provide all the information necessary to implement data standards for study data submissions.

Therefore, this guidance refers to a number of technical specifications and other resources associated with the use of data standards that are intended to help submitters determine which data standards to use and how to use them. These technical specifications and resources are referenced online to make them more accessible to the submitters. In some cases, the online resources are maintained by standards development organizations (SDOs) and not by FDA.

To find this draft guidance please use the below mentioned FDA weblink

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292334.pdf