Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

Do Drugs Given Expedited Approval Have More Safety Risks? GAO Says US FDA Can't Tell

This article was originally published in SRA

Executive Summary

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.