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Clinical Data Integrity: Clean US FDA Inspection No Guarantee That DoJ Won’t Investigate

 
• By Sue Sutter

Justice department has investigative tools that can uncover fraudulent activity even when a clinical site passes inspection, DoJ’s Clint Narver says; in deciding whether to self-report possible clinical trial fraud to FDA and DoJ, sponsors should consider that other companies would benefit from knowing this information about a particular site or investigator.  

Escalator
Drug sponsors need to have clear processes in place for escalating concerns about clinical data fraud. • Source: Shutterstock

A “glowing” US Food and Drug Administration inspection may not protect a pharmaceutical sponsor, contract research organization or site investigator from a Department of Justice investigation into potential clinical trial fraud.

Although DoJ looks at an entity’s inspectional history, that may not tell the full story in terms of whether fraud...

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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

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UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
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What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

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