ARTICLE | Regulation

The promise and problems of expediting drug approvals

Overview of status of expedited approval pathways sets stage for BioCentury’s 29th Back to School

August 30, 2021 12:59 PM UTC

FDA’s accelerated approval pathway has produced enough success stories to conjure a vision of how drug development and treatment paradigms could be transformed if expedited pathways were to become the norm.

The pathway has triggered the creation of parallels in other countries, and is credited with transforming drug development for and treatment of cancer...