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.

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