The On- and Off-Ramps of Oncology Accelerated Approval
Lola A. Fashoyin‐Aje, Gautam U. Mehta, Julia A. Beaver, Richard Pazdur
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.
Topics & Concepts
MedicineDrug approvalMEDLINEOncologyInternal medicineIntensive care medicinePharmacologyPolitical scienceLawDrugStatistical Methods in Clinical TrialsHealth Systems, Economic Evaluations, Quality of LifeBiomedical Ethics and Regulation