Expanded Access Requests EA eRequest Scope Currently available for single patient requests: Initial non-emergency requests Documentation for already-authorized emergency requests (with IND) Follow-up submissions
Expanded Access | Information for Physicians | FDA Expanded Access eRequest External Link Disclaimer allows physicians to electronically request use of medical products for patients Guidance Documents
Expanded Access | Keywords, Definitions, and Resources | FDA This webinar also provides an overview of FDA’s expanded access program and introduces participants to resources like the EA eRequest site hosted by the Reagan-Udall Foundation for the FDA
PowerPoint Presentation Summarize the key responsibilities of the oncology healthcare professional when considering expanded access for a patient