📊FDA Seeks Comments on RWD Submissions Using HL7 FHIR Standards
The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket for public comments exploring the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) for submission of data collected from real-world data (RWD) sources. In alignment with the new Department of Health and Human Services (HHS), Assistant Secretary for Technology Policy/Office of the National Coordinator for Health (ASTP/ONC) policy on health information technology (health IT), the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are exploring approaches to optimize the submission of structured and standardized clinical study data collected from RWD sources. FDA is seeking public comment from interested parties on specific questions. Interested parties may include regulated industry, health IT vendors, academic medical centers, and electronic data capture vendors as well as other interested parties.
Learn More💊FDA Biosimilars User Fee Program
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
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