FDA, Industry Weigh Specialized Review Pathway For Complex Generics

Generic drug industry stakeholders named the creation of a specialized review pathway for complex abbreviated new drug applications as a priority during user fee negotiations, and the agency has discussed with generic drug manufacturers the need for more clarity from FDA in the pre-ANDA space, according to meeting minutes. FDA drug center chief Janet Woodcock told Inside Health Policy that FDA would like to develop methods to characterize and evaluate bioequivalence of these complex products so that manufacturers won't...