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FDA Updates on Standardized Study Data Submissions and E2B(R3) Electronic Safety Reporting
The US Food and Drug Administration (FDA) has published updated technical guidance documents addressing standardized electronic study data submissions and the electronic transmission of Individual Case Safety Reports (ICSRs). The Study Data Technical Conformance Guide – Technical Specifications Document and the E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide provide technical recommendations to support consistent data structures, electro
Sharan Murugan
8 hours ago4 min read