24 January 2012

GlobalSubmit: News Letter - US FDA eSubmission Updates

In the first Quarter of 2012 the GlobalSubmit Newsletter covered the following information.

Module 1 Changes Scheduled for Spring 2012 - by Rahul Mistry, CEO 

The draft version of the US eCTD Module 1 was completed in June 2011, and appeared on the Federal Register (FR) docket on October 26, 2011. This draft contains major changes, and can be found here. As is typical with FR notifications of this nature, public comments can be made for 60 days after appearing on the docket, meaning that comments were able to be submitted up until December 27, 2011. The public comments and internal FDA change requests will be reviewed and analyzed to determine whether any modifications are necessary to the draft.

The State of FDA Implementation  - by Jason Rock, CTO 

The FDA has performed extensive testing on the load performance, validation criteria, usability of validation reports, and updates to how the submission is sorted in GlobalSubmit REVIEW.

The FDA is a unique client, as it has over 4,000 users and over 200,000 sequences. The FDA looks at validation reports to determine if the sequence is reviewable and helps sponsors create higher quality sequences.
PDUFA V and the Impact on You  - by Jason Rock, CTO

In September, the FDA issued its Proposed PDUFA V Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017.

There are many proposed improvements related to the FDA review procedures, including a mandate of the eCTD. This mandate will start 24-months after publication of the corresponding final guidance for marketing applications and 36-months after publication of the final guidance for commercial INDs and amendments.

The final guidance will be released no later than 12 months from the close of a public consultation period on the draft guidance. The corresponding draft guidance will be issued by December 31, 2012 at the very latest. The initial guidance will reference eCTD version 3.2.2; however, the final guidance might refer to a different standard, namely RPS, if the FDA determines the new standard is more efficient and effective. The FDA also mentions that they "shall also accept submissions using the previous version for no less than twenty-four (24) months."

To find more information use the below mentioned weblink

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