The Reagan-Udall Foundation for the FDA, with input from experts at FDA, has introduced an Expanded Access eRequest app to streamline expanded access for individual patients in non-emergency settings.

“Time is critical when patients have a serious or life-threatening disease or condition and do not have other therapeutic options,” FDA Principal Deputy Commissioner Amy Abernethy said in a statement. “We want to make it easier for physicians to apply for expanded access for their patients and allow these health care providers to focus on the clinical aspects of care.”

Ask the Accelerators is a series highlighting the perspectives and work of organizations and individuals participating in the COVID-19 Evidence Accelerator. Organized by the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) and Friends of Cancer Research, the COVID-19 Evidence Accelerator joins leaders in the health care data and analytics space to explore how real-world data (RWD) can inform key COVID-19 research questions. 

When a patient is in need of an important medicine, paperwork and forms are the last thing their physician wants to deal with. In some cases, it’s necessary, but the U.S. Food and Drug Administration is doing everything we can to keep it to a minimum. Our expanded access program is one example.