Real-World Evidence Uptake Is “Silver Lining” Of COVID-19 Response, USFDA’s Abernethy Says
The coronavirus pandemic highlights the work that is still needed on real-world evidence, agency's principal deputy commissioner says.
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Established by five real-world data and analytics companies, the new group provides a collective seat at the table for legislative and policy development conversations about real-world evidence and an organized channel of communications with the US FDA.
Steve Cutler, head of the CRO that conducted Pfizer’s study, tells the Pink Sheet that starting clinical trials in weeks, as opposed to months, should be possible post-pandemic.
Follow-up bill to the 21st Century Cures Act looks to be more focused on reimbursement and delivery than the 2016 law, which centered on speeding drug development and approval. The bill's architects are working to get some of their provisions, including those around antibiotics, attached to the next COVID-19 relief legislation.