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.
- The European Patients’ Academy (EUPATI) is a pan-European project implemented as a public-private partnership by a collaborative multi-stakeholder consortium from the pharmaceutical industry, academia, not-for-profit, and patient organizations.
- EURORDIS is a non-governmental patient-driven alliance of patient organisations representing 884 rare disease patient organizations in 72 countries. Here is their position on compassionate use.
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