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.

Sincerely,
Patient Strategies & Solutions,
Office of the Chief Medical Officer

General PAA Information Resources

• Terms and definitions frequently utilized when discussing pre-approval access.
• Guide to Expanded Access (PDF)
• 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

• KidsVCancer Compassionate Use Navigator
• Reagan Udall Foundation Expanded Access Navigator
• New York University Working Group on Compassionate Use & Pre-Approval Website
• ClinicalTrials.gov