FDA Posts eCTD Validation Specifications v2.2

Yes that’s right, 2.2! As you may know, FDA started using Validation Criteria 2.1 on 30 April. In the 2.1 spec all the new/changed items had an “Effective Date” of “Pending”. All 2.2 does is change all the “Pending” to “4/30/2013”. No items were added/deleted/changed. Click here to download the new 2.2 version specifications from the FDA website.

And don’t forget to validate your own eCTDs with v 2.1/2.2 specs now!