CDER Conversations
Reflecting on Biosimilar User Fee Amendments (BsUFA) II and preparing for the BsUFA III reauthorization process
In this CDER Conversation, Dr. Sarah Yim, M.D., director of the Center for Drug Evaluation and Research (CDER) Office of Therapeutic Biologics and Biosimilars discusses BsUFA.
BsUFA allows FDA to collect user fees, which create a reliable funding source that helps ensure the timely review of biosimilar and interchangeable biological products.