FDA-TRACK: Expanded Access (Compassionate Use) Submission Data
Relevant Links:
- • Expanded Access | Information for Patients
- • Expanded Access | Information for Physicians
- • Expanded Access | Information for Industry
- • Expanded Access | Information for Institutional Review Boards (IRBs)
- • Expanded Access | How to Submit a Request (Forms)
- • Aceso ampliado | Información para los pacientes
- • Expanded Access for Medical Devices
First enacted in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA User Fee Reauthorization Act of 2022, reauthorizes FDA to assess and collect fees for generic drug products from October 2023 through September 2027. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and improve upon the predictability of the review process.
On this page:
The Expanded Access (EA) submission data are now available in interactive dashboards. The dashboards include the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) expanded access submission receipt reports for INDs and Protocols from Fiscal Year (FY) 2010 – FY 2025 and the Center for Devices and Radiological Health (CDRH) expanded access requests from FY 2014 to FY 2025.