Blog — Clinical Pathways

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FDA Investigation

New Guidance for Industry on The Use of Real-World Evidence and Electronic Health Records in Regulatory Decision-Making

08/02/2024

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On July 25, 2024 the US Food and Drug Agency (FDA) published a final guidance for industry “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.” This guidance is intended to help sponsors and other interested parties determine whether or not to use electronic health records (EHR) or medical claims data (information submitted to insurers to receive payments for treatments and other interventions) when making regulatory decisions on the effectiveness or safety of a drug.

FDA Issues Warning Letter to IRB Following BIMO Inspection

04/23/2024

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On March 21, 2024 the Centre for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) issued a warning letter to the New York State Psychiatric Institute (NYSPI) institutional review board (IRB). The FDA’s inspection resulted in six major observations, all of which occurred during convened IRB meetings.