More than 100 to potentially 200 generic drug applications have been downgraded to a not substitutable rating after the US Food and Drug Administration uncovered a substantial data integrity problem at two contract research organizations, forcing sponsors to scramble to restore their products’ prior status.
More Than 100 Applications Lost Equivalence Rating Thanks To Allegedly Falsified Data At Two CROs
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.
