Topic: Policy: Accelerated Approval Pathway

Strengthening the FDA’s Accelerated Approval Pathway

Apr 2021 | Policy Paper

This paper aims to create a clearer understanding of both the opportunities and challenges inherent in the FDA’s accelerated approval pathway (AAP), and to present an analysis of the potential risks and benefits of a range of reform options that policymakers may consider in efforts to strengthen the AAP moving forward.    Date of publication: […]