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.
You may also be interested in...
What ‘Confirmatory Evidence’ Does US FDA Need When Sponsors Want To Rely On A Single Trial?
Amylyx’s Relyvrio survival data, drawn from a post hoc exploratory survival analysis of randomized patients, and the primary ALS functional endpoint ‘capture distinct concepts,’ FDA states. Use of long-term survival data from the same trial as confirmatory evidence was unusual, but not unique.
Clinical Research Needs To Move ‘Out Of The Ivory Tower,’ FDA’s Woodcock Urges
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.
BIO 2021 Notebook: Biogen CEO On Corporate Responsibility
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.