Re­or­ga­ni­za­tion of OND to sup­port new drug re­view mod­ern­iza­tion, Wood­cock says

The re­or­ga­ni­za­tion of the FDA’s Of­fice of New Drugs will help sup­port the mod­ern­iza­tion of new drug re­views, Janet Wood­cock, head of the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search told at­ten­dees of RAPS’ Reg­u­la­to­ry Con­ver­gence on Thurs­day.

She said the plan is to be­gin re­struc­tur­ing the pre­mar­ket safe­ty re­view process and then move in­to the in­ves­ti­ga­tion­al new drug (IND) ap­pli­ca­tion process.

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