Did Novo Nordisk Sidestep Protocol Requirements For Novoeight In India?
Executive Summary
Novo Nordisk appears to be facing some regulatory turbulence pertaining to Novoeight (turoctocog alfa) in India after it was pulled up by an expert panel for an alleged deviation around a Phase IV protocol requirement for the coagulation factor product. The company, however, claims it is in “full compliance” with Indian regulatory norms.
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