After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.

Justice department has investigative tools that can uncover fraudulent activity even when a clinical site passes inspection, DoJ’s Clint Narver says; in deciding whether to self-report possible clinical trial fraud to FDA and DoJ, sponsors should consider that other companies would benefit from knowing this information about a particular site or investigator.

Back as Strides managing director, founder Arun Kumar is confident of reversing a slide in profits via a recalibration strategy that saw the company exit Canada and a few European markets. Meanwhile, eyes are on the fallout of a CRO that serviced Strides apart from Sandoz, Teva and more getting caught in CHMP and FDA’s crosshairs.