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About EAPs

Expanded access programs (EAPs) are part of an effort by the FDA and pharmaceutical companies to make investigational drugs available during the later stages of clinical development.

To be considered for an EAP by the FDA, the investigational drug must: (Chart)

Next: How to register and participate in this program

  1. U.S. National Institutes of Health. An Introduction to Clinical Trials. Available at: http://www.clinicaltrials.gov/ct/info/whatis#expanded. Accessed July 18, 2007.