FDA's (Federal Drug Administration) Reviews of New Drugs: Changes Needed in Process for Reviewing and Reporting on Clinical Studies
Abstract
Assuring American consumers that new drugs and biologics entering the marketplace are safe and effective is a responsibility of the Food and Drug Administration (FDA). Through inspections and reviews, FDA's Division of Scientific Investigations attempts to verify the integrity of scientific testing and the reliability of test data submitted to FDA in support of new drug applications. GAO reviewed the Division's activities, including its responsibilities relating to the approval of new drug and biologic products; the accuracy of FDA data and adequacy of oversight regarding clinical investigators, institutional review boards, and toxicology laboratories involved in studies supporting new drug applications; FDA's review of studies by clinical investigators supporting new drug applications; the adequacy and timeliness of for-cause (specially requested) inspections; and enforcement actions resulting from the Division's work. GAO also examined the timeliness of the Division's inspections.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 01, 1988
- Accession Number
- ADA200501
Entities
Organizations
- United States Government Accountability Office