Starting with ADC, FDA calls for fully enrolled confirmatory trial prior to accelerated approval submission

Zachary Brennan

Senior Editor

When Congress punted on adding new accelerated approval reforms to the user fee legislation, many wondered how and when the agency would get around to …

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Starting with ADC, FDA calls for fully enrolled confirmatory trial prior to accelerated approval submission

Zachary Brennan

Senior Editor

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VP, Clinical Development / CMO / CDO‬ ‭ (Stealth Portfolio Company)

Autonomy Bio Inc.

San Francisco, CA 94107, USA

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Start­ing with ADC, FDA calls for ful­ly en­rolled con­fir­ma­to­ry tri­al pri­or to ac­cel­er­at­ed ap­proval sub­mis­sion

Senior Editor

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Autonomy Bio Inc.

San Francisco, CA 94107, USA

Starting with ADC, FDA calls for fully enrolled confirmatory trial prior to accelerated approval submission