More Than 100 Applications Lost Equivalence Rating Thanks To Allegedly Falsified Data At Two CROs

 
• By Derrick Gingery

Sponsors must decide whether to repeat bioequivalence and other studies after two CROs were found to have potentially falsified data, causing the US FDA to reject all data produced by the firms.

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Because the data integrity of some studies came into question, the FDA said all data from two CROs was not reliable. • Source: Alamy

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