DMF cross-reference

Know how applicants reference confidential DMF information

Role: CMC/RA Coordinator

Context: Your API supplier has a Type II DMF. You need FDA to review it as part of your NDA.

Task: Choose what you need from the supplier.

Step 1 of 1

Select document

info

You cannot include the supplier’s confidential DMF content in your NDA without authorization.

What do you request from the supplier so FDA can reference the DMF?