CTD Section 1.3.6 Report
Summary
Section Name:
Tropical disease priority review voucher
Section Code:
1.3.6
Module Number:
1
Description:
Document to request a priority review voucher for a drug product to treat an indication on an approved list of tropical diseases
Submission Timing
Not applicable to gene therapies
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources