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Pediatric Oncology Advances Could Prompt More FDA-Required Studies

 
• By Mary Jo Laffler

Findings being presented at ASCO next month could signify major increase in targets relevant to pediatric oncology, meaning sponsors should prepare for more US FDA-required studies under the RACE for Children legislation.

IV solution in a child's patients hand - Image

Pediatric oncology received a major policy boost from the RACE for Children provisions in the US FDA Reauthorization Act, and new research being presented at the American Society of Clinical Oncology annual meeting highlights how much better focus is being brought to the field of pediatric oncology.

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What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

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EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

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• By Vibha Sharma

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DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

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