“We have real-world evidence, a successful phase three study, and we're going to bring up that NEJM article to the FDA.”
MR
Mark Robbins client
FDA Watch ·
“Key takeaway… engage FDA early and often… using pre-IND meetings and the phase two and type C meetings to show… why one trial is sufficient.”
Mark Robbins, client · FDA Watch · The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals
Play from 25:53
25:53
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What was described
Engage FDA early via pre-IND, phase-2 and type-C meetings to explain why one trial is sufficient and outline confirmatory evidence plan
Said nearby on the same subject
“We do audit logs, but now in the agentic world, we have to also give more insights why an agent arrived to a decision. What's the evidence they use? And when did they use what evidence? It's traceability and explainability.”
♫
Said on The CPG Guys
“FDA recommends sharing your protocol and statistical analysis plan before the real-world study is conducted… to ensure the analysis wasn’t cherry-picked.”
MD
Meryl Dersarkissian
FDA Watch ·
“I'm using Claude. This is my last newsletter because I explain that with the $100 plan, you get six times more usage than on the $100 plan of Chadupt.”
♫
Said on Agency Intelligence: The Insurance Podcast Network
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