US FDA's Oncology Division Wants To Know About Your Pipeline, Not Just Your NDAs
Oncology Center of Excellence Director Richard Pazdur says agency invites sponsors to present about molecules under development to learn more about future plans.
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Oncology division officials summarize the agreements and discussions reached during formal meetings so there are no misunderstandings later. Sponsors want the practice used more widely by the FDA.
Agency willing to talk to generic sponsors about complex product issues, but it can avoid the resource-intensive process by updating product-specific development guidances.
Success of enhanced communications in particular made one stakeholder wonder whether FDA could use it with non-breakthrough applications.