Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Glossary Definition

EXPANDED ACCESS
A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial. One of several Study Types.

For more information on expanded access programs, visit the FDA Understanding Expanded Access/Compassionate Use Web site .