RWE Alliance
Time 2022-10-09 07:44:24Web Name: RWE Alliance
WebSite: http://www.rwealliance.org
ID:345688
Keywords:
RWE,AllianceDescription:
We are a coalition of real-world data and analytics organizations with a common interest in harnessing the power of real-world evidence to inform regulatory decision making to improve patients’ lives.
Latest News
Press Releases • Washington, D.C. 5 April 2022
Five Leading Real-World Data and Analytics Organizations Join the RWE Alliance, Doubling MembershipPress Releases • Washington, D.C. 9 March 2022
RWE Alliance Submits Comments on All Four Recent FDA RWE Guidances, Looks Toward Further Engagement to Advance Use of RWE to Benefit PatientsPress Releases • Washington, D.C. 24 January 2022
RWE Alliance Submits Comments on FDA’s RWE Draft Guidance, Highlights Recommendations for Agency’s RWE Program and RWE Derived from EHR/Claims DataRWE Alliance Comments to FDA
FDA's Draft Guidance on Considerations for Use of RWD/EIn December 2021, FDA issued draft guidance entitled “Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products.” This draft guidance outlines various regulatory considerations for submissions containing RWD/E.
SEE THE RWE ALLIANCE COMMENTS FDA's Draft Guidance on Data RegistriesIn November 2021, FDA issued draft guidance entitled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry.” This draft guidance provides recommendations for using RWD derived from data registries to support regulatory submissions.
SEE THE RWE ALLIANCE COMMENTS FDA's Draft Guidance on Data Standards for Regulatory Submissions Containing RWDIn October 2021, FDA issued draft guidance entitled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” This draft guidance provides recommendations for applying FDA’s currently supported data standards to submissions containing RWD.
SEE THE RWE ALLIANCE COMMENTS FDA's Draft Guidance on Electronic Health Records/Medical Claims (EHR/Claims) DataIn September 2021, FDA issued draft guidance entitled “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products.” This draft guidance provides recommendations for using real-world evidence derived from electronic health records and medical claims data for regulatory decisions across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.
SEE THE RWE ALLIANCE COMMENTSHarnessing the power of RWE
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