Do Drugs Given Expedited Approval Have More Safety Risks? GAO Says US FDA Can't Tell
This article was originally published in SRA
The US Government Accountability Office (GAO) gave the Food and Drug Administration a negative report card on its post-market oversight of drugs approved with a fast track or breakthrough therapy designation, finding the agency's data on safety issues for these drugs is unreliable and difficult to access.
Register for our free email digests: