Topics from GDUFA 3 Reauthorization Meeting

A 12/17/20 meeting of FDA and industry representatives to negotiate the reauthorization of GDUFA covered these topics, according to a meeting summary distributed by the agency: 

•          industry asked the agency to consider harmonizing some technical terminology related to the mid-cycle discipline review letters with a publicly-facing policy document;
•          FDA described and provided data on the steady increase in post-marketing changes submitted through post-approval supplements and changes being effected supplements and said that additional resources may be needed if the supplement volume continues to increase;
•          FDA shared similar information on the steady and continued annual increases in controlled correspondences, often covering complex generic drug products; and
•          FDA opened an initial discussion of a possible proposal to resource more timely consideration of suitability petitions.