Recent news
June 2010
FDA review group to focus on drugs for neglected tropical diseases
A US Food and Drug Administration (FDA) review group for rare diseases held its first public meeting this week, examining how to make it easier and less expensive to develop products for diseases that affect less than 200,000 people in the United States. The hearing could provide insights to the first public hearing of the FDA’s review group for neglected tropical diseases later this fall. When the neglected tropical diseases review group meets, it will examine what role the FDA can play to advance global health products. Several recommendations on this issue were put forth at a recent hearing held in the Senate. See the links below for more information.
- Reuters
- Department of Agriculture Fiscal Year 2010 appropriations bill, which establishes FDA’s mandate to convene the two review groups (237 KB PDF)
- Global Health Technologies Coalition report on Senate FDA hearing
- Global Health Technologies Coalition resources on the FDA
- FDA’s “Guidance for industry: Tropical disease priority review vouchers”
