Yes, direct authorization to reference the DMF is needed because the FDA only has authorization to review the DMF for the NDA holder. To "use" the DMF, the investigator-sponsor will need a letter of authorization from the DMF holder to file with the IND. The DMF holder will also need to submit a letter to FDA allowing FDA to review the DMF once the investigator-sponsor files the IND. The DMF holder also submits an update list to the DMF with the investigator-sponsor added to the list of authorized companies/sponsors to reference the DMF.
Best,
Dar
------------------------------
Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
------------------------------
Original Message:
Sent: 26-Oct-2022 13:00
From: Anonymous Member
Subject: DMF for Investigator Initiated IND
This message was posted by a user wishing to remain anonymous
Direct reference to the DS-DMF is the most appropriate pathway! Else FDA would request during review of the research IND in the initial 30 day review.
Original Message:
Sent: 25-Oct-2022 18:11
From: Anonymous Member
Subject: DMF for Investigator Initiated IND
This message was posted by a user wishing to remain anonymous
Hi RAPS Community,
My company is in the process of providing a LoA to a investigator-sponsor for a research IND in the US.
The research IND will refer to our commercial IND for CMC information. However, our commercial IND itself refers to a DMF for the drug substance, which is commercially available. Our drug product is in a different dosage form, thereby necessitating the IND.
Our question is whether if the investigator-sponsor will need to directly refer to the DS DMF? Or would the reference to our commercial IND be considered sufficient?
Thank you for your help.