CTD Section 1.12.10 Report
Summary
Section Name:
Generic drug enforcement act statement
Section Code:
1.12.10
Module Number:
1
Description:
A statement required by the Generic Drug Enforcement Act of 1992 certifying that the applicant did not and will not use the services of a person debarred in connection with the application; and (2) if the application is an ADA, a list of all convictions within the last five years of the applicant and affiliated persons responsible for the development or submission of ADAs.
Submission Timing
Not applicable to gene therapies
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources