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.
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The final guidance will be released no later than 12 months from the close of a public consultation period on the draft guidance. The corresponding draft guidance will be issued by December 31, 2012 at the very latest.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."