Sponsors with generic products that have been stripped of their bioequivalence ratings because of data integrity problems at two contract research organizations may want regulatory flexibility from the US Food and Drug Administration, but generally appear to have only two choices.
Will US FDA Offer Regulatory Flexibility For ANDAs Downgraded Because Of CRO Investigation?
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.
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