Submitting biologics applications to the Center for Biologics Evaluation and Research electronically

The Food and Drug Administration (FDA) has gained significant experience with computer-assisted licensing applications, and has concluded that continued reliance on customized formats is a burden for the FDA and industry. As a result, the FDA is working to standardize the content and format of electronically submitted applications, and to establish procedures for electronic applications that will: create minimal additional work for industry and reviewers, establish consistency across the FDA's centers, and expedite the review process. The FDA is proposing to move to a paperless regulatory process by the year 2002. Toward that goal, the FDA's Center for Biologics Evaluation and Research (CBER) has released new guidance for the electronic submission of biologic and product license applications; case report forms, tabulations, and statistical data; and lot release protocols. A pilot program for Investigational New Drug applications also has been initiated.