ARTICLE | Politics & Policy

FDA releases final guidance on tropical disease vouchers

October 5, 2016 7:00 AM UTC

In new final guidance, FDA clarified a handful of aspects of its tropical disease Priority Review voucher program. The document updates draft guidance from 2008.

The new guidance said FDA cannot remove qualifying diseases from the program if they are listed in the Food Drug and Cosmetic Act, and clarified the circumstances under which new diseases may be added, including a pathway for public recommendation. ...