FDA's Plans to Improve Processing of Medical Device and Drug Applications
IMTEC-89-58, Jun 13, 1989
Pursuant to congressional requests, GAO reviewed the Food and Drug Administration's (FDA) ability to timely process medical device and drug applications.
GAO found that the FDA Center for Devices and Radiological Health prepared an automatic data processing system plan to improve the quality and timeliness of medical device application reviews and alleviate paperwork storage problems by: (1) allowing reviewers to access application documents simultaneously; (2) eliminating transportation of documents between center locations; and (3) permanently storing original documents on optical disks to eliminate delays resulting from lost or misplaced documents. GAO also found that, although the FDA Center for Drug Evaluation and Research has not prepared an overall automation plan to improve its drug review and approval process, its 5-year information resources management strategic plan includes ongoing activities to: (1) integrate independent software applications by modifying them to use its database management system; (2) support pilot tests involving electronic submission of application data; (3) allow drug firms a greater role in drug review and approval; and (4) train personnel to carry out drug evaluations and education and research projects.