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In August 2025, FDA issued the draft guidance, Approaches to Assessment of Overall Survival in Oncology Clinical Trials. This guidance is based in part on discussions held at a joint FDA, American Association for Cancer Research (AACR), and American Statistical Association (ASA) public workshop held in July 2023. It also puts into writing feedback that I have received from the Agency on oncology clinical trials and guidance that I have related to our oncology clients.
REGULATORY CORNER
Welcome to PROMETRIKA’s Regulatory Corner. In this space, our experts will offer their insights in an approachable manner on specific initiatives from global regulatory authorities and discuss regulatory trends impacting the development of medical products. We hope you will check in regularly for these overviews.
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