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    FDA Offers Regional Specifications on Submission of ICSRs for Drugs and Biologics

    The US Food and Drug Administration (FDA) on Wednesday released the technical specifications to assist interested parties in electronically submitting individual case safety reports (ICSRs) and ICSR attachments to its Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The 19-page specifications document describes FDA’s technical approach for submitting ICSRs, for incorporating regional terminology, and for adding ...