Accelerated Approval Great For “Me-Too” Products, FDA Says
CDER’s Bob Temple explains how competitors could actually help speed up a drug approval but also hold a product to a higher standard.
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Accelerated approvals likely to increase, particularly for cancer, predicts FDA’s Temple.
A handy side-by-side chart shows the criteria, advantages and timelines for the fast-track, breakthrough therapy and priority review designations and the accelerated approval pathway.