The On- and Off-Ramps of Oncology Accelerated Approval

Lola A. Fashoyin‐Aje · Gautam U. Mehta · Julia A. Beaver · Richard Pazdur

81 citations0/0 files storedNew England Journal of Medicine

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Pharmaceutical Economics and Policy Healthcare Regulation Biomedical Ethics and Regulation

Abstract

To address ongoing concerns about the implementation of the FDA’s Accelerated Approval pathway in oncology, a comprehensive strategy is needed — one that equally emphasizes “on-ramp” and “off-ramp” considerations.

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