
RWE Alliance Comments to FDA
In December 2021, FDA issued draft guidance entitled “Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products.” This draft guidance outlines various regulatory considerations for submissions containing RWD/E.
In November 2021, FDA issued draft guidance entitled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry.” This draft guidance provides recommendations for using RWD derived from data registries to support regulatory submissions.
In October 2021, FDA issued draft guidance entitled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” This draft guidance provides recommendations for applying FDA’s currently supported data standards to submissions containing RWD.
In September 2021, FDA issued draft guidance entitled “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products.” This draft guidance provides recommendations for using real-world evidence derived from electronic health records and medical claims data for regulatory decisions across therapeutic areas.
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