Evaluation of Incentives for Development of Orphan Medical Foods

摘要

The report addresses the legislative and regulatory framework and criteria for the definition of orphan status, diseases that could be managed by medical food products, the adequacy of current incentives for the development of orphan medical foods, barriers to the development of these products and recommendations for the future. The report contains the Orphan Drug Act, representative medical food products for rare diseases, and 42 literature citations.