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
General PAA Information Resources
- 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.
- Background article on obtaining pre-approval access and common misperceptions
United States Food and Drug Administration Resources
- FDA Expanded Access Program
- Information on Form FDA 1571
- Information on Form FDA 3926
- Information about FDA Project Facilitate
Additional Helpful Links