CTD Section 1.12.3 Report
Summary
Section Name:
Request to charge for expanded access
Section Code:
1.12.3
Module Number:
1
Description:
Request seeking FDA approval to charge participants for expanded access use, and accompanying supporting documentation
Submission Timing
Initial IND or IND amendments (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources