|  FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | FDA Issues Draft Guidance on Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drugs and Biologics The U.S. Food and Drug Administration issued a draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. The draft guidance includes recommendations for sponsors, researchers, and other interested stakeholders proposing to use data from electronic health records (EHRs) or medical claims to help support a new use of an FDA-approved drug or biological product or to help support or satisfy post-approval study requirements. The draft guidance includes considerations for selecting fit-for-use real-world data from EHR or medical claims databases to help answer research questions of interest. The draft guidance also provides considerations for defining treatment exposure, outcomes, and other important elements in a study. The draft guidance also includes considerations for data quality assurance and data quality control procedures. The recommendations in this draft guidance are relevant for all study designs aiming to use EHR or medical claims data to help demonstrate a drug or biological product's safety or effectiveness for regulatory purposes. This draft guidance is part of a series of guidances that FDA plans to publish in support of the agency's RWE Program. Issuing this draft guidance helps satisfy FDA's mandate under the 21st Century Cures Act and meets a Prescription Drug User Fee Act goal to issue guidance on using real-world evidence for regulatory decisions on drug safety or effectiveness. | | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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