FDA to re­lease list of sur­ro­gate end­points in on­col­o­gy

Scott Got­tlieb, FDA Com­mis­sion­er, said Mon­day at the Na­tion­al Press Club in Wash­ing­ton, DC that his agency will re­lease a list of sur­ro­gate end­points used in can­cer drug de­vel­op­ment soon.

His speech touched on four top­ics — in­clud­ing mod­ern­iz­ing the tri­al process and en­abling pay­ers to lever­age more open ac­cess to re­al world da­ta. “In the com­ing weeks, for the first time, CDER will pub­lish on the web, a list of the sur­ro­gate end­points that were the pri­ma­ry ba­sis of ap­proval or li­cen­sure of a drug or bi­o­log­i­cal for both ac­cel­er­at­ed and tra­di­tion­al ap­provals,” he said.

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