Food and Drug Administration Reinvention Goal:

More Efficient Drug Development

Initial Goal Statement (December, 1997):

Current Goal Statement:

Date of Revision:

Forecast Completion Date:

Status:

ANDAs: Guidance on submitting regulatory data for ANDAs in electronic form was published this fiscal year. Guidance on electronic ANDAs (for archive) will be published in FY 2001. Based on current performance goals, the implementation of full electronic ANDAs would precede that of INDs and Annual Reports; however, CDER may decide to reorder these priorities.

FDA's accomplishment of reauthorizing the user fee program set the stage for added improvement to provide drugs in a timely manner to the American people. By the end of FY 1999, the Agency will notify 70 percent of requesters within 14 days of a request for a formal meeting and 80 percent by the year 2000. To further accelerate the drug development process, FDA has classified meetings so that the most critical questions can be addressed within 30 days of the sponsor's request. The Industry Meeting Tracking system (IMTS) is fully operational with review divisions entering meetings into the system. PDUFA meetings guidance to industry was issued in March and the comment period ended in May. Comments are currently being reviewed.

Automation is a significant contribution to improved internal efficiencies, and helps to accelerate FDA's review of product applications. In FY 2000, FDA will process 75 percent of all review documents by implementing an Electronic Document Management System (EDMS) throughout new and generic drug review divisions. The EDMS will provide for the creation, electronic signature, routing, and archival of internally generated review documents, thereby reducing the administrative burden on reviewers and allowing them more time to spend on higher-value scientific review activities. The electronic document management system is operational. An enhanced version is under development and will be released late1999.

Location in FY 1999 Strategic Plan:

Location in FY 1999 Performance Plan:

Location in FY 2000 Performance Plan:

1. Establish the capability and capacity to receive and archive Abbreviated New Drug Applications (ANDAs) submitted electronically. (Page 58)

2. Process 75 percent of all review documents by implementing an Electronic Document Management System (EDMS) throughout new and generic drug review divisions. (Page 59)