Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spot­light on the ac­cel­er­at­ed ap­proval path­way con­tin­ues to shine bright, with the FDA’s top on­col­o­gy of­fi­cial writ­ing in an opin­ion that the path­way may be strength­ened with bits and pieces of what oth­er reg­u­la­tors in Eu­rope and else­where have done with their ex­pe­dit­ed ap­proval path­ways, such as adding ex­pi­ra­tion dates for these faster ap­provals to en­sure they con­firm clin­i­cal ben­e­fit in a time­ly man­ner.

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