title: Designating Additions to the Current List of Tropical Diseases in   the Federal Food, Drug, and Cosmetic Act. Final order.
abstract: The Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes the Food and Drug Administration (FDA or Agency) to award priority review vouchers (PRVs) to tropical disease product applicants when the applications meet certain criteria. The FD&C Act lists the diseases that are considered to be tropical diseases for purposes of obtaining PRVs, and also provides for Agency expansion of that list to include other diseases that satisfy the definition of ``tropical diseases'' as set forth in the FD&C Act. FDA has determined that Chagas disease and neurocysticercosis satisfy this definition, and therefore is adding them to the list of designated tropical diseases whose product applications may result in the award of PRVs. Sponsors submitting certain applications for the treatment of Chagas disease and neurocysticercosis may be eligible to receive a PRV if such applications are approved by FDA.
mesh_terms: D014355:Chagas Disease; D003906:Developing Countries; D017277:Drug Approval / Q000191:economics* / Q000331:legislation & jurisprudence*; D006078:Government Programs / Q000191:economics / Q000331:legislation & jurisprudence; D006801:Humans; D017387:Investigational New Drug Application / Q000191:economics / Q000331:legislation & jurisprudence; D007880:Legislation, Drug; D020019:Neurocysticercosis; D014330:Tropical Medicine / Q000331:legislation & jurisprudence*; D014481:United States