ACT Brief: Tavneos Trial Integrity Issues, Selective Safety Data Regulatory Pathways, and FDA PreCheck Program Launch

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.