FDA Revises Guidance on Electronic Drug Submissions

The FDA issued a final guidance on online submissions for certain drug product applications, clarifying that some submission types are exempt or may qualify for a waiver.

The revised guidance made clear that no Type III drug master file (DMF) submissions have to be made in electronic common technical document (eCTD) format, although the agency encourages sponsors to submit them in an alternative electronic format, such as PDF files following the CTD style.

All non-commercial INDs — drugs not intended for commercial distribution — are also exempt, including research and investigator-sponsored INDs.