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Latest From Flatiron Health Inc.

Cures 2.0 Likely To Push US FDA To Further Embrace Real-World Evidence

Draft legislation, which has a good chance of getting wrapped into the next user fee bill, doesn’t give FDA any new authorities or firm mandates on real-world evidence but should nudge agency to more quickly adapt to using RWE for regulatory purposes.

Real-World Evidence Post Market Regulation & Studies

Real-World Data: FDA Urged To Distinguish Between Electronic Health Records And Medical Claims

Comments on September draft guidance seek more attention to differences between the two types of data sources; pharma firms said they may not always have access to all the information the US FDA wants to see about a particular data source, and they seek additional flexibility on validation.

Real-World Evidence Guidance Documents

Real-World Evidence More Helpful To US FDA In Cases Of High Clinical Trial Efficacy

Pfizer-funded systematic review of approved oncology applications that contained RWE highlights common deficiencies flagged by FDA and says strength of trial data is a key determinant of the extent to which RWE is needed and considered by the agency.

Real-World Evidence Drug Review

Data Firms Form Real-World Evidence Alliance, Giving Them A Voice With US FDA, Congress

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.

Real-World Evidence Legislation
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