Eu­ro­pean watch­dog wants to man­age “risks” of ear­ly con­tacts be­tween reg­u­la­tors, bio­phar­ma

→ At the FDA, the fo­cus is on get­ting start­ed as ear­ly as pos­si­ble in talks with bio­phar­ma com­pa­nies aimed at guid­ing de­vel­op­ment of new drugs. But those ear­ly, pre-sub­mis­sion in­volve­ments are at­tract­ing the scruti­ny of a Eu­ro­pean watch­dog who is sus­pi­cious of con­tacts be­tween reg­u­la­tors and drug de­vel­op­ers. In a let­ter to EMA chief Gui­do Rasi, EU om­buds­man Emi­ly O’Reil­ly notes: “(S)uch ac­tiv­i­ties may pose some risks, such as that the even­tu­al de­ci­sions by EMA on the au­tho­ri­sa­tion of med­i­cines may be in­flu­enced by what has been dis­cussed dur­ing the meet­ings with med­i­cine de­vel­op­ers pri­or to re­ceiv­ing their mar­ket­ing au­tho­ri­sa­tion ap­pli­ca­tion. I note that EMA sees pre-sub­mis­sion meet­ings as a way to “en­able med­i­cine

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