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    Strategies for Smarter Compliance in a Technology-Driven FDA Environment

    The article provides an overview of the significance of technology in the regulatory compliance process and offers strategies for smarter compliance. Introduction Come May 2017, the US Food and Drug Administration (FDA) will no longer accept submissions of drug applications that do not follow the electronic Common Technical Document (eCTD) format. This signifies further movement toward the use of technology in regulatory approvals and a key milestone in the modernizat...