Speeding Up the Drug Review Process: Results Encouraging -- But Progress Slow.
Abstract
The Food and Drug Administration's efforts to speed drug review are encouraging. Since October 1, 1978, FDA has approved more drugs in less time than before despite an increased workload. The greatest reductions were made in approvals of important drugs (drugs that in FDA's judgment provide a therapeutic gain over any marketed drugs). However, these approvals represent only about 41 percent of those in process since October 1, 1978, and it is too early to tell whether the positive trend will continue. Reduction of approval time has not been consistent throughout all FDA divisions, and processing times should be further reduced. GAO is recommending actions that the Secretary of Health and Human Services could take to further reduce drug review time. (Author)
Document Details
- Document Type
- Technical Report
- Publication Date
- Nov 23, 1981
- Accession Number
- ADA111554
Entities
Organizations
- United States Government Accountability Office