Electronic Submissions: Data Standards; Support and Requirement for the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide-Animal Rule Version 1.0
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The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing support for the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Implementation Guide--Animal Rule Version 1.0 (SENDIG-AR v1.0) on March 26, 2024, and this standard will be required in submissions to CBER for studies that start after March 15, 2027. The Agency will update the FDA Data Standards Catalog (Catalog) to reflect this change.
Abstract as published in the Federal Register.
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