Скачать или смотреть Submission Tips - Single Patient Expanded Access

The process for non emergency Expanded Access, including FDA and IRB (institutional review board) submissions, can be daunting. This video provides tips for these submissions from the experience of TEAMSS collaborators.

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 FDA Resources
00:29 Emergency versus Non Emergency
00:43 Form FDA 3926
00:55 Indication for Treatment
01:18 Clinical History
02:13 Treatment Information
03:00 Fields 10a and 10b
03:12 Submit to FDA
03:49 IRB Submission
04:15 What to do if you don't have a local IRB

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.