Expanded Access Policy

Fortvita Biologics (USA), Inc. is a clinical-stage pharmaceutical company focused on the research and development of proprietary investigational products.

Investigational drug products are generally available only to participants in clinical studies, as they have not been approved by the U.S. Food and Drug Administration (FDA) as safe and effective for their intended use. While the FDA’s Expanded Access Program (sometimes called “compassionate use”) allows manufacturers to provide investigational products to certain patients who meet specific criteria under FDA regulations, Fortvita Biologics (USA) is not currently offering expanded access outside of clinical trials and is not accepting expanded access requests at this time.

For questions or more information about our program, please contact Fortvita Biologics (USA) at ClinicalDevelopment@fortvitabio.com.

In accordance with the 21st Century Cures Act, Fortvita Biologics (USA) may revise this policy at any time.