AbbVie, industry group push for international compromise on when trial investigators should receive unblinded data

AbbVie and industry group TransCelerate Biopharma are taking issue with the FDA’s attempt to change when certain IND safety reports should be unblinded.

Back in June, the FDA released a new draft guidance that lays out when certain safety reports should be unblinded prior to their submission to FDA and all participating investigators. But that stipulation puts the agency in conflict with EU guidance calling for such reports to be blinded.