FDA Releases Draft Guidance on Standardizing Electronic Submission of Study Data

Posted 17 February 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released new draft guidance for industry on 17 February on how sponsors and applicants may submit standardized study data to FDA in electronic form.

The draft guidance, Providing Regulatory Submissions in Electronic Format - Standardized Study Data, applies to sponsors of investigational new drug applications (INDs), new drug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).

The document intends to "promote the use of data standards in the electronic submission of study data to FDA," and "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."

FDA hopes that encouraging standardized electronic submissions will help its review centers process and review applications more efficiently.

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