FDA Delays New eCTD Module 1

At last week’s DIA Annual Meeting in Boston the FDA announced that the long awaited new eCTD Module 1 would be delayed until June 2014. In addition, the FDA is changing the DTD. So, if you have been waiting for the FDA to start accepting the new M1 so you could add your documents into those 4 new sections at the end of M1, you’re going to have to wait about another year longer.