Speaker: Rachel Capone, MSHS (Syner-G BioPharma Group)

The FDA has made it a key priority to support the development and evaluation of new treatments for rare diseases. The FDA has the authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition. This presentation will discuss the overall Orphan Drug Designation program and process and include Orphan Drugs, Rare Diseases, the Orphan Drug Act (ODA), Orphan Drug Designation Program, Benefits of ODD, ODD Requests and a Review of Criteria.