Electronic Submission Program Expands into INDs for Biologics

The US Food and Drug Administration (FDA) is soliciting certain members of the biopharmaceutical industry to participate in a new pilot program that will help it determine whether its eSubmitter Program (eSubmitter) helps in the development and submission of investigational new drug (IND) applications.

Background

FDA has been transitioning many programs to digital formats, such as the electronic common technical document (eCTD), in the hope that it will allow agency review staff to review those applications in less time while also allowing it to make better use of the data within the application.

In January 2013, FDA announced the expansion of the eSubmitter system for requesting export certificates for medical device product exports, calling it a "win" for both the agency and the industry because it will allow both to submit and process requests more "efficiently and expeditiously."

With electronic submissions, CDRH can more readily receive and process the export requests," the agency wrote. "The electronic process will help fulfill both the legislative and application time processing requirements set out by [statute] and the terms of clearance of the Office of Management and Budget approval."

The tool is already used for a number of other program areas, including the submission of individual case safety reports, adverse event reporting, facility self-identification, drug registration and listing,eCopy, medical device reporting and animal drug submissions.

Expanding Use of the eSubmitter System

Now the system is getting new use as a tool for the submission and review of INDs to FDA's Center for Biologics Evaluation and Research (CBER), part of a process aimed at updating and enhancing the center's regulatory review process, it said.

The six-month pilot program will see new sponsors of INDs "complete their IND application submissions using the eSubmitter template developed by FDA that has been specifically designed for use by IND sponsors," FDA explained in a Federal Register notice on 8 April 2013.

"To create the IND application, the participant will enter the requested information into the eSubmitter tool and attach requested documents as an Adobe document (pdf format)," FDA said. "This information will be saved onto a CD-ROM by the sponsor and mailed to CBER for review."

This process will avoid the need for paper submissions, which are ordinarily required.

FDA explained that only new IND applications and associated amendments will be able to participate in the program, and that FDA staff will be made available to assist in the application process.

"As each application is completed, the users will be asked to comment on the eSubmitter program. These comments and discussions will assist CBER in the final development and release of this electronic program for use by industry," FDA added.

Applications for the program are due by 8 July 2013.