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    Demystifying Electronic Data Standards for Clinical and Nonclinical Studies

    As part of the Prescription Drug User Fee Act IV ( PDUFA IV ) information technology commitments, the US Food and Drug Administration (FDA) is moving toward a fully electronic, standards-based submission and review environment. 1 FDA has issued a series of guidance documents to assist sponsors in providing regulatory submissions in electronic format. In the latest draft guidance, Providing Regulatory Submissions in Electronic Format-Standardized Study Data 2 , issu...