FDA’s Office of New Drugs: A Regulatory Policy Primer

This session will provide an overview of how new drugs are brought to market and regulated by the US Food and Drug Administration (FDA), featuring experts from the FDA’s Center for Drug Evaluation and Research. During the session we will address: • How researchers can find and use the FDA’s publicly available resources • Programs and policies related to new drug approvals • Research questions of interest to the FDA • Opportunities for engagement with the FDA • 20-minute Q&A with FDA policy experts