FDA to Require Mandatory Electronic Submission of Most Applications 

FDA announced a much anticipated schedule for mandatory electronic submission of most market approval applications (NDA, BLA, ANDA, DMFs, etc), and INDs. In a new
 Guidance Document released on 15 May 2015, FDA will only accept NDA, BLA, ANDA, and Master Files via its electronic submission gateway (ESG) in the CTD format starting 15 may 2017, and not accept any paper INDs starting 15 may 2018. At present, electronic submission of an application to the FDA is optional with the applicant choosing to submit either paper documents or electronically via the ESG. Although, in the last few years the percent of market approval applications submitted via ESG have steadily increased with more than 80% of market approval applications submitted electronically in the year 2014, there are still a few sponsors who prefer paper submissions. FDA has been encouraging and supporting increased electronic submissions by publishing several guidance documents, presentations at conferences and workshops, and providing application-specific suggestions to sponsors, however by the dates listed above, FDA expects the sponsors to fully transition to electronic submissions. However, this rule does not apply to non-commercial INDs such as investigator-lead INDs, emergency use INDs, and treatment INDs, which will still be accepted in paper format, although sponsors of those INDs will have the option to submit electronically if they want. Sponsors of IND and market approval applications to FDA now have a strict deadline by which to become proficient in all aspects of electronic submissions as deficient application will be automatically rejected by FDA and will not even be reviewed. This rule adds to the ones that already exist for mandatory electronic submission of medical device reporting, drug and biologic adverse event reporting, and promotional labeling and advertisements.