CUPA FAQs English

At NYU Langone’s Working Group on Compassionate Use and Preapproval Access (CUPA), our list of frequently asked questions (FAQ) is an invaluable resource for learning about access to investigational medical products and associated topics. The answers below pertain only to the United States; policies for preapproval use vary by country. The information here is accurate as of August 2025. If you are interested in learning about policies for obtaining access to unapproved medical products outside the United States, see Janssen Pharmaceuticals’ guide to expanded access.