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FDA releases draft guidance on Providing Regulatory Submissions in Electronic Format

bio_subbu

Super Moderator
#1
Dear All

The US Food and Drug Administration (USFDA) issues a draft guidance document entitled ‘Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Standardized Study Data’

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”, and that the agency “recognizes 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”.

For more details please refer the FDA link, this guidance document is published for comment purposes only.

Regards
S. Subramaniam
 

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Stijloor

Staff member
Super Moderator
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Re: FDA releases draft guidance on Providing Regulatory Submissions in Electronic For

A Quick Bump!

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Thank you very much!!

Stijloor.
 
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