Single Patient Expanded Access to Investigational New Drugs - Overview

Описание: Don't know what to expect when requesting expanded access to an investigational drug for your patient? This video describes the steps to obtain approval for treatment under expanded access.

Expanded Access is the FDA (‪@US_FDA‬) pathway that allows the clinical use of investigational products for patients who have serious or life threatening illnesses and no comparable or satisfactory therapeutic options.

Chapters:
00:00 - What is Expanded Access?
00:44 - Step 1: Manufacturer Approval
01:01 - Step 2: FDA Submission
01:16 - Step 3: Institutional Review Board (IRB)
01:37 - Step 4: Treat Your Patient
01:51 - Step 5: Follow-up Submissions

More resources for Expanded Access are available at TransformingExpandedAccess.org.

This video was produced by Transforming Expanded Access to Maximize Support and Study (TEAMSS), sponsored by the National Center for Advancing Translational Science (‪@NCATSMedia‬) grant U01 TR002488.