BioCentury
ARTICLE | Regulation

Stretching the vision of accelerated approval

A learning system across pre and postmarket studies, bringing more drugs to more patients in more diseases

September 3, 2021 1:00 PM UTC

There are two co-existing views of FDA’s accelerated approval pathway. It has been a grand success for cancer treatment, an area it has revolutionized. It has also been an underperformer, doing little for almost any other disease, and has been tainted by controversy.

The future is more optimistic. ...



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