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.
You may also be interested in...
Trade association’s CEO says a new strategic planning initiative will consider among other things how gene therapy could fit into the generic industry business model.
Watson (now Teva) and InvaGen (now Cipla) failed to submit new bioequivalence data following enforcement action against Cetero Research.
Data integrity spotlight expands beyond cGMP as FDA finds Semler manipulated study subject samples in bioequivalence studies conducted at its Bangalore facility.