Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act

Zusammenfassung

The Federal Food, Drug, and Cosmetic Act (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 tropical diseases for purposes of obtaining PRVs and provides for Agency expansion of that list to include other diseases that satisfy the definition of "tropical diseases" eligible for PRVs as set forth in the FD&C Act. The Agency has determined that two foodborne trematode infections, opisthorchiasis and paragonimiasis, satisfy this definition, and is therefore adding them to the list of designated tropical diseases whose product applications may result in the award of PRVs. Sponsors submitting certain drug or biological product applications for the prevention or treatment of opisthorchiasis or paragonimiasis infections may be eligible to receive a PRV if such applications are approved by FDA.