It would depend on the product. Please refer to the attached guidance page 28. Hope this helps.
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Mehul Govani RAC
Regulatory Affairs Manager
Westbury NY
United States
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Original Message:
Sent: 04-Oct-2018 10:33
From: Anonymous Member
Subject: Type II API DMF
This message was posted by a user wishing to remain anonymous
Are type II DMFs submitted to the US FDA expected/required to include section 3.2.A.2 Adventitious Agents Safety Evaluation information?