Snapshot

The Tropical Disease Priority Review Voucher Program pathway has been developed by the of United States.

This pathway can be used where The term "tropical disease product application" is defined in section 524(a)(4) of the FD&C Act. The term refers to an application that is: (1) A human drug application as defined in section 735(1) of the FD&C Act: For prevention or treatment of a tropical disease; and That the FDA deems eligible for priority review. (2) The term also refers to an application approved by the FDA after the date of the enactment of FDAAA for use in the prevention or treatment of a tropical disease. This definition includes applications for drugs submitted under section 505(b) of the FD&C Act and applications for most biological drugs, including vaccines, submitted under section 351(a) of the PHS Act, but excludes applications for blood components and certain other biological drug products. The definition does not cover applications for medical devices. (3) For a human drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under section 505(b)(1) of the FD&C Act or section 351 of the PHS Act..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Not applicable.