CRO Inspection Fall-Out: Semler's Clients Have To Repeat Studies
This article was originally published in The Pink Sheet Daily
Data integrity spotlight expands beyond cGMP as FDA finds Semler manipulated study subject samples in bioequivalence studies conducted at its Bangalore facility.
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Complex generic may have some wiggle room, but the only choice for many sponsors may be to redo the affected studies or withdraw the products that have lost bioequivalence status after FDA questioned the integrity of the data from two contract researchers.
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.
Watson (now Teva) and InvaGen (now Cipla) failed to submit new bioequivalence data following enforcement action against Cetero Research.