The tools provided below contain helpful information in understanding how we approach pre-approval access (PAA) at Janssen. We hope you find these helpful and welcome your questions or comments via email at [email protected].
Thank you for your interest on behalf of patients everywhere.
Office of the Chief Medical Officer
INFORMATION ABOUT JANSSEN PRE-APPROVAL ACCESS POLICY & PROCEDURES
Janssen policy regarding pre-approval access requests and how they are handled.
Infographic: Key tenets from the Janssen policy for evaluating pre-approval access requests.
An overview of Janssen principles for pre-approval access.
INFORMATION ABOUT THE COMPASSIONATE USE ADVISORY COMMITTEE (COMPAC)
Watch: A three-minute video talking about how CompAC works.
Infographic: Key results from Janssen’s first CompAC pilot program.
ADDITIONAL HELPFUL TOOLS
Terms and definitions frequently utilized when discussing pre-approval access.
Important considerations and questions for patients to discuss with their physician and caregivers regarding investigational medicines.
Single Patient Expanded Access infographic outlines key steps for treating physicians to identify and submit requests to pharmaceutical companies as well as the requirements for FDA and IRB review.
This FDA form is what a treating physician would use to submit a compassionate use request on behalf of his/her patient (in order to access Form FDA 3926, this link must be opened in Internet Explorer).
This article provides background knowledge on how to gain access to unapproved drugs and common misconceptions regarding approval.