CDER Planning Guidances On Single-Trial Approvals, Real-World Evidence
US FDA drugs center’s ambitious guidance agenda lists 105 new or revised guidances, most of which carried over from the prior year; new to the list are three guidances each on real-world data and individualized antisense oligonucleotide drug products, and a document focused on demonstrating efficacy with a single adequate and well-controlled trial.
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Acting Commissioner says she is ‘really going to be pushing’ to have clinical trials conducted in the community. CDER’s Cavazzoni and CBER’s Marks discuss master protocols, decentralized trials, and real world evidence at DIA’s annual meeting.
News and views from day four of the BIO Digital annual meeting include the FDA's plans to use carrots not sticks to improve diversity and reflections on how the pandemic has strengthened biopharmaceutical supply chains.