JD Supra

FDA Issues New Form FDA 3926 and Final Guidance for Its Use, a New Approach for Physicians to Request FDA Approval for Expanded Access to Investigational Drugs for Individual ...

Agency Also Finalizes Additional Guidance Regarding Expanded Access (“Compassionate Use”) - On June 2, 2016, the Food and Drug Administration (FDA) issued final guidance “Individual Patient Expanded ...
Health Affairs

Individual Patient Expanded Access: Developing Principles For A Structural And Regulatory Framework

Individual patient expanded access, sometimes termed “compassionate use,” refers to situations where access to a drug still in the development process is granted to patients on a case-by-case basis ...