It has been nearly three decades since the US Food and Drug Administration instituted the accelerated approval regulations, and Oncology Center of Excellence Director Richard Pazdur thinks it is high time that the pathway – and all FDA’s expedited programs – get a second look.
Pazdur included a re-examination of accelerated approval on a “wish list” of discussion topics for the entire oncology community in the lead-up to any potential “21st Century Cures” 2.0 legislation....
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