Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

In response to initial IND application, the FDA has requested us for a letter requesting other drugs manufactured at our manufacturer. Our CMO does not want to give us this info by themselves and currently do not have a DMF. What type of DMF would they submit to FDA for this one page response listing drugs manufactured at the same facility?

This message was posted by a user wishing to remain anonymous

I don't believe they can file a DMF for this information only. At the most i would suggest you provide them the contact information for your FDA RPM and have the CMO directly email them a letter with that information, and indicate that it is confidential and not to be shared with your company.
Original Message:
Sent: 26-Feb-2020 19:43
From: Anonymous Member
Subject: Master file

This message was posted by a user wishing to remain anonymous

In response to initial IND application, the FDA has requested us for a letter requesting other drugs manufactured at our manufacturer. Our CMO does not want to give us this info by themselves and currently do not have a DMF. What type of DMF would they submit to FDA for this one page response listing drugs manufactured at the same facility?