Description: The assessment aid (AAid), an initiative of the US Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE), was introduced in 2018 as a pilot program to help streamline the agency’s review of oncology drug applications. The main objective of the AAid is to focus the agency’s review on the most critical aspects of the dossier to increase review efficiency and consistency, and decrease review time spent on administrative tasks. The AAid is often combined with other OCE pilot programs such as the real-time oncology review (RTOR) and Project Orbis. This session will focus on experience with the Assessment Aid as well as recommendations for preparing this document and improving the process to fully realize its benefits.
Learning Objectives:
Describe experience to date with the Assessment Aid.
Discuss recommendations for preparing the Assessment Aid and improving the process to fully realize its benefits.
Upon completion, participants will have a better understanding of the Assessment Aid, its value and challenges associated with it