Advancing the Development of Medical Products Used In the Prevention, Diagnosis, and Treatment of Neglected Tropical Diseases; Public Hearing

摘要

The Food and Drug Administration (FDA) is announcing a public hearing to solicit general views and information from interested persons on issues related to advancing the development of medical products (drugs, biological products, and medical devices) used in the prevention, diagnosis, and treatment of neglected tropical diseases. In particular, FDA is seeking these views and information from interested persons on preclinical studies, trial design, regulatory approaches, and optimal solutions as they relate to the prevention, diagnosis, and treatment of neglected tropical diseases. To help solicit such views and information, FDA is seeking comments on specific issues (see section IV of this document).