In today’s ACT Brief, we examine who decides what trials measure, how designing for human thinking improves site execution, and how the FDA extended an immunotherapy to a new bladder cancer population.
News|Podcasts|July 1, 2026
ACT Brief: Tavneos Trial Integrity Issues, Selective Safety Data Regulatory Pathways, and FDA PreCheck Program Launch
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine a major trial retraction and regulatory action against a rare disease drug, regulatory scenarios for selective safety data collection, and FDA's domestic manufacturing incentive program.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- The New England Journal of Medicine
retracted the pivotal Tavneos trial paper after FDA investigation found patient outcome data were altered and unblinded personnel manipulated results, prompting CDER to propose withdrawing the drug's approval. The EMA's human medicines committee simultaneously recommended revoking Tavneos' European authorization, concluding benefits no longer outweigh risks including drug-induced liver injury and vanishing bile duct syndrome with fatal cases. - In a new video
interview , Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, explained how four jointly developed regulatory scenarios give sponsors a blueprint for adopting selective safety data collection with greater confidence and stronger FDA alignment. These scenarios address practical implementation challenges while preserving the agency's ability to conduct rigorous safety oversight. - FDA
selected seven companies for its PreCheck Pilot Program from 80+ requests. The program offers early regulatory guidance and expedited facility review to incentivize domestic pharmaceutical manufacturing and strengthen US drug supply chain resilience.
That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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