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Expanded Access: FDA To Clarify How Adverse Events Impact Drug Approval Process

 
• By Brenda Sandburg

GAO says lack of clear information from FDA may influence whether manufacturers grant expanded access to investigational drugs; only two clinical holds have been due to adverse events from expanded access use.

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The US Government Accountability Office (GAO) had only one recommendation for FDA after reviewing its expanded access program: the agency should clearly communicate how it uses adverse events data from the program in reviewing a drug for approval.

In a recent report, GAO said some manufacturers and other stakeholders contend that FDA is not clear about how it uses expanded access adverse events data in its...

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