“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.”
MR
Mark Robbins client
FDA Watch ·
“We have real-world evidence, a successful phase three study, and we're going to bring up that NEJM article to the FDA.”
Mark Robbins, client · FDA Watch · The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals
Play from 23:59
23:59
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What was described
Submit a single pivotal trial plus confirmatory real-world evidence to FDA, citing the NEJM article to argue for a one-trial approval
Said nearby on the same subject
“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 ·
“Drive to Canada… bring a drug back across the border that the FDA has not approved but is approved in Canada called Vigabatrin.”
SW
Steve Wellings
The Empowered Parent with Dana Baltutis ·
“If you want to upload a book to Amazon, you have to sort of submit some kind of documentary evidence of having written it, either yourself reading it or you have to submit a photo of your messy desk...”
♫
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