CTD Section 1.12.17 Report
Summary
Section Name:
Orphan drug designation
Section Code:
1.12.17
Module Number:
1
Description:
This section is where the sponsor should discuss their product's status as an orphan drug (if applicable) or to include FDA correspondence about the sponsor's plans to request orphan drug designation for their product. This section should NOT be used to request an orphan drug designation. FDA designation requests should be submitted separately, but can be concurrent with the initial IND submission or a later amendment. If you have an Orphan Drug Designation letter, include that here.
Submission Timing
Initial IND or IND amendments (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources