It can be done and IND/CTA can be amended to identify the product being used. You don't mention whether the comparator has been "modified" to blind the treatments - if so, may need to consider whether the modification matters in the release and stability of the modified DP. EU countries may want submission of the details of the sourcing of the generic.
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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 14-Dec-2022 17:45
From: Anonymous Member
Subject: Branded vs Generic Comparator Drug for Clinical Trials
This message was posted by a user wishing to remain anonymous
Hello All,
Does anyone have experience with clinical trials, where the sponsor needed to switch comparator drug product from a branded comparator to a generic comparator after the study has already started. Specifically, we were using a brand name comparator and the material is out of stock. Therefore we now need to source a generic, that is bioequivalent, for the remaining of the study. Would the US and EU approve this change as there is no more branded material available. This is the same situation in the US and in the EU. The generic DP in the US is approved in the US. The generic DP in the EU is approved in the EU.
Thank you,
ANON