Abstract
The industry and the Food and Drug Administration (FDA) are working together to ease the transition of new drug applications (NDAs) into computer-assisted NDAs (CANDAs). To insure that CANDAs are reviewable one must have a solid understanding of the regulatory review process and the ways in which automation can enhance that process. This paper presents the Center for Drug Evaluation and Research’s (CDER) efforts to prepare for a future of electronic submissions.
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