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House GOP Targets US FDA Applications With China-Only Data, Cites General Oversight Concerns

 
• By Derrick Gingery

While industry concern with FDA’s policy shift on clinical data from China has focused on the disruption in business plans, Republican lawmakers appear to feel that the agency has not gone far enough and are seeking a GAO review of FDA’s entire bioresearch monitoring program.

US-China chess pieces
House GOP leaders requested the GAO review BIMO's challenges overseeing research in the US and overseas. • Source: Shutterstock

House Republicans are probing the FDA for information about drug development in China amid concerns about applications submitted with data generated only in that country.

In a 20 May letter to US Food and Drug Administration Commissioner Robert Califf, Reps. Cathy McMorris Rodgers, R-WA, Brett Guthrie, R-KY, and Morgan Griffith, R-VA, who are the...

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