FDA Postmarket Guidance Hammers Home Positions On Foreign Trials, Real-World Evidence
US agency emphasizes and formalizes long-standing viewpoints on hot topics including accelerated approval in a new guidance on postmarket study diversity.
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Robust natural history data sets with well-chosen outcomes are fundamental in Aetion’s regulatory feasibility tool for real-world evidence, built through analysis of US FDA case studies and guidance.
Agency clarifies expectations for non-interventional studies providing RWD to support regulatory decisions while continuing to emphasize familiar themes around early interaction and stringent data practices.
Natural History Studies: Launch With Care And Consider Alternative Evidence For Drug Approval, FDA’s Marks Says
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.