Third party review
This article was originally published in The Gray Sheet
Executive Summary
"We will soon be notifying Congress that we believe we have met" one of the sunset criteria in the latest expansion of the third-party program, FDA's Eric Rechen reports June 15 during the AdvaMed workshop. The sunset provision triggers the termination of authority for the program in five-years unless Congress reauthorizes it. GAO is required by law to conduct several studies to help Congress evaluate the program prior to the expiration of the third party program, however, Rechen notes. By the end of this year, the Office of Compliance will have audited "all of the most active third parties," Rechen also adds