PMR/Cs for Novel Oncology Therapies

Using data from publicly available approval letters and review documents in FDA’s Drugs@FDA database, Friends created this dashboard to evaluate trends in the types of data collected through PMR/Cs and identify questions that frequently remain at the time of approval for novel oncology drugs approved over the last decade. 

The dashboard displays data on PMR/Cs issued at the time of initial approval for novel oncology therapies between January 1, 2012, and December 31, 2023. It can be used to evaluate the types of data requested to be collected in the postmarketing setting and gain insights on trends across different approval years, drug classes, indications, and more. Novel therapies are drugs and biologics that have not received prior approval by the FDA. Supplemental approvals and supportive agents are not included in the dashboard.