In celebration of the 25th anniversary of the Orphan Drug Act, FDA, industry and patient advocacy groups are coming together to discuss accomplishments, perspectives, globalization, and future challenges in the development of therapeutic drugs and devices for the treatment of rare diseases.
Current updates on the processes, procedures, and resources to enable the successful movement of products for rare diseases from research to approval will be discussed. This will include information on Orphan Drug Designation applications,
Humanitarian Use Device designation applications, and Orphan Products Grant applications as well as other regulatory components.