Archive

This document was downloaded and archived from http://www.fda.gov/ope/nprstat98/drugstat.htm  on May 29, 2001.

Food and Drug Administration Reinvention Goal:

More Efficient Drug Development

Status Report: August 2000

Initial Goal Statement (December, 1997):

By the year 2000, reinvent the drug development and review process, thereby lowering the development costs, and, more importantly reducing by an average of one year the time required to bring important new drugs to the American public. FDA will accomplish this through early and frequent consultation with product sponsors, implementation of an automated application filing process, and reauthorization of an enhanced user fee program.

Current Goal Statement:

By the year 2000, reinvent the drug development and review process, thereby lowering the development costs and, more importantly, reducing by an average of one year the time required to bring important new drugs to the American public. FDA will accomplish this through early and frequent consultation with product sponsors, implementation of an automated application filing process and an electronic document management system, and reauthorization of an enhanced user fee program.

Date of Revision:

March 1999

Forecast Completion Date:

Year 2000

Status:

NDAs: Guidance on full electronic NDAs (for archive) was published. Agency is now ready to receive and review NDAs electronically. Previously, only case report forms and tabulations were being received and reviewed electronically.

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:

HHS Objective 6.5: Accelerate private-sector developing of new drugs, biologics, therapies, and medical technology.

Location in FY 1999 Performance Plan:

Goal Statement: Continue to achieve capacity for electronic submission and archiving of new drug applications (NDAS), abbreviated new drug applications (ANDAs), and abbreviated antibiotic drug applications (AADAs).

Location in FY 2000 Performance Plan:

Goal Statements:
  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)

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