Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions

Non-binding Guidance: Real-World Evidence in Drug Developmen...

Non-binding Guidance

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The fourth installment of Ropes & Gray’s podcast series, Non-binding Guidance, dives into the use of real-world evidence in drug development. In this episode, Ropes & Gray lawyers Kellie Combs and Sarah Blankstein discuss FDA’s current thinking on real-world evidence and how industry has been using real-world evidence studies in FDA submissions, as well as with payors and in product promotion. The speakers highlight key takeaways from FDA’s frame...
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The fourth installment of Ropes & Gray’s podcast series, Non-binding Guidance, dives into the use of real-world evidence in drug development. In this episode, Ropes & Gray lawyers Kellie Combs and Sarah Blankstein discuss FDA’s current thinking on real-world evidence and how industry has been using real-world evidence studies in FDA submissions, as well as with payors and in product promotion. The speakers highlight key takeaways from FDA’s frame...
Read More