12 January 2012

FDA: Public Meeting on Proposed Recommendations for a Human Generic Drug User Fee For Fiscal Years 2013 through 2017 – Updates about an eSubmission

The Fifth and Final Generic Drug User Fee public meeting held on Monday, December 19, 2011. At FDA office, Maryland. 

The following eSubmission updates captured in this meeting.

- Push industry to move more towards an electronic submission. Because the eSubmission will enhances the efficiency of the Regulatory Submission Review process.

 - During the meeting question asked to FDA staff regarding the eSubmission.  

Question: What is the expectation for living/legacy documents such as DMFs? Do you expect them to be resubmitted in ECTD format or other electronic format?

FDA Staff Answer: Yes, The negotiation was FDA is quite Cognizant that the current submission are in a variety of formats. So that the Goal is clear, we require the submissions to be in electronic format and will issue the standards for that electronic format. FDA will not ask resubmissions of the documents that are already in the directory however the new submissions  and amendments needs to be in electronic format that has been specified for GDUFA submissions.


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