CTD Section 1.12.18 Report
Summary
Section Name:
Regenerative medicine advanced therapy (RMAT) designation
Section Code:
1.12.18
Module Number:
1
Description:
This section is where the sponsor should discuss their product's RMAT status (if applicable) or to include FDA correspondence about the sponsor's plans to request this designation for their product. This section should NOT be used to request an RMAT designation. FDA designation requests should be submitted separately, but can be concurrent with a later amendment
Submission Timing
IND amendments (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
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