Natural History Studies: Launch With Care And Consider Alternative Evidence For Drug Approval, FDA’s Marks Says

 
• By Sue Sutter

A different evidence-generation approach may lead to a quicker approval than leveraging a natural history study, CBER Director Peter Marks says; EveryLife Foundation's Annie Kennedy says participation in natural history studies can empower patients who are not eligible for drug-specific clinical trials.

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Launching natural history studies requires careful consideration, CBER Director Peter Marks said. • Source: Shutterstock

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