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RWE Alliance Comments to FDA

Policy Document • Comments

FDA's Draft Guidance on Considerations for Use of RWD/E

In December 2021, FDA issued draft guidance entitled “Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products.” This draft guidance outlines various regulatory considerations for submissions containing RWD/E.

Policy Document • Comments

FDA's Draft Guidance on Data Registries

In November 2021, FDA issued draft guidance entitled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry.” This draft guidance provides recommendations for using RWD derived from data registries to support regulatory submissions.

Policy Document • Comments

FDA's Draft Guidance on Data Standards for Regulatory Submissions Containing RWD

In October 2021, FDA issued draft guidance entitled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” This draft guidance provides recommendations for applying FDA’s currently supported data standards to submissions containing RWD.

Policy Document • Comments

FDA's Draft Guidance on Electronic Health Records/Medical Claims (EHR/Claims) Data

In September 2021, FDA issued draft guidance entitled “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products.” This draft guidance provides recommendations for using real-world evidence derived from electronic health records and medical claims data for regulatory decisions across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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