FDA out­lines a laun­dry list of sur­ro­gate end­points with an eye to ex­pand­ing the ros­ter for drug de­vel­op­ers

The FDA on Wednes­day pub­lished a list of sur­ro­gate end­points to help in­form drug de­vel­op­er dis­cus­sions with rel­e­vant Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search (CBER) or Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) re­view di­vi­sions.

The list, which was cre­at­ed thanks to the 21st Cen­tu­ry Cures Act, in­cludes sur­ro­gate end­points that spon­sors have used as pri­ma­ry ef­fi­ca­cy clin­i­cal tri­al end­points for ap­proval of new drug ap­pli­ca­tions (NDAs) or bi­o­log­ics li­cense ap­pli­ca­tions (BLAs). It al­so in­cludes sur­ro­gate end­points that may be ap­pro­pri­ate for use as pri­ma­ry ef­fi­ca­cy clin­i­cal tri­al end­points for drug or bi­o­log­ic ap­provals, al­though they have not yet been used to sup­port an ap­proved NDA or BLA.

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