Highest-ever Electronic Submissions at CDER

An electronic submissions update at a recent DIA regulatory submissions, information, and document management forum indicated that there were 14,700 electronic submission gateway submissions to CDER in 12/2015, making it the highest month ever for electronic submissions. CDER Division of Data Management Services and Solutions director Ginny Hussong also said that more than 1,600 new Module 1 submissions had come in as of 2/1/15. Electronic submissions include 88% of study data submitted in support of new NDAs.

Hussong reminded attendees that 5/5/17 is the deadline for required eCTD submissions for NDAs, BLAs, ANDAs, and DMS, while 5/5/18 is the deadline for commercial INDs. Paper and non-eCTD submissions will no longer be accepted after those deadlines.

Other FDA presentations (linked from above link) included an eCTD validation update and global identification of medicinal products.