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Real-World Data: US FDA Sets High Bar For Electronic Health Records, Claims In Applications

 
• By Sue Sutter

Demonstrating that electronic health record and medical claims datasets are fit for purpose, and addressing potential limitations in advance, are key themes of new draft guidance.

High bar
US FDA has set high expectations for sponsors seeking to use real-world data in product application submissions. • Source: Alamy

A new draft guidance from the US Food and Drug Administration sets a high bar for sponsors to establish that electronic health records and medical claims data are fit for purpose in demonstrating the effectiveness or safety of drugs and biologics.

The

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UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

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EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
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The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

Why Successful Companies Are ‘Tough On Themselves’ When It Comes To HTA

 
• By Eliza Slawther

Pharmaceutical companies need to “pressure test” their clinical development strategies early for health technology assessment purposes, particularly in light of the new EU HTA Regulation, a life sciences consultant says.

Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
• By Neena Brizmohun

Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

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US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
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US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

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US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
• By Laura Helbling

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