Article

Prior Sponsor Oncology Accelerated-Approval Activity and Post-Approval Regulatory Outcomes: A Retrospective Cohort Study

2026-08-25

Abstract excerpt

<title>Abstract</title> <p>Background Post-approval evidence generation is central to the FDA accelerated approval pathway, but whether prior sponsor participation in oncology accelerated approval is associated with later regulatory outcomes is unclear. Methods We studied 122 FDA oncology accelerated-approval product-indication pairs approved in 2013–2022 and followed through August 21, 2026. Prior activity req...

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Literature Corpus work: 965962d4-217b-5bc6-96c9-0d5ff5eed7f2
DOI: 10.21203/rs.3.rs-10787826/v1

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