Abstract
The Interactive Investigational New Drug/New Drug Application (IND/NDA) process is an innovation in the review and approval process pioneered in the Pilot Drug Evaluation Division of the Food and Drug Administration (FDA). It is a collaborative arrangement between the sponsor and reviewing division whereby much of the adversarial nature of the review is eliminated and efficiency of review is increased. The key to the process is the close and often informal interactions between the sponsor and FDA, early input by agency staff and the advisory committee on the soundness of the clinical development plan, and the fostering of scientist-to-scientist communications. The Interactive IND/NDA is a positive step in industry/agency relations and represents an improvement in the review and approval process.
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