Wood­cock de­tails up­com­ing changes to NDA and BLA re­view process

A mod­ern­iza­tion of the way the FDA re­views NDAs and BLAs will be in­sti­tut­ed over the next two years, Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) Di­rec­tor Janet Wood­cock told at­ten­dees of the Food and Drug Law In­sti­tute’s an­nu­al con­fer­ence on Thurs­day.

Six ac­tive ini­tia­tives re­lat­ed to this mod­ern­iza­tion are on­go­ing at CDER, in­clud­ing ini­tia­tives fo­cused on in­te­grat­ed re­views for mar­ket­ing ap­pli­ca­tions, IND ap­pli­ca­tion re­view man­age­ment, post-mar­ket safe­ty man­age­ment, as­sess­ing tal­ent (Wood­cock said CDER is still un­der-staffed), re­or­ga­ni­za­tion man­age­ment and ad­min­is­tra­tive op­er­a­tions.

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