Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,
My company is completing a hepatic impairment clinpharm study as a postmarketing requirement for our NDA and plans to submit a clinpharm labeling supplement to include recommended dose adjustment for mild, moderate, and severe hepatic impaired patients. We will have a complete clinpharm study report with datasets as well as clean and tracked changes PIs for our sNDA submission. For such a labeling sNDA, is any Module 2 clinical summary required? -- this is an oncology product. 

Thank you for sharing your experience.

This message was posted by a user wishing to remain anonymous

Let me put it this way, if you don't submit the summary, you will not get a RTF (i.e. refuse to file) and should the FDA needs it, they will ask you during the first 60 days! If you want to be conservative just submit it! No big deal! The most import thing is the CSR and the draft labeling components.
Original Message:
Sent: 05-Dec-2022 14:58
From: Anonymous Member
Subject: Clinpharm Labeling sNDA for hepatic impairment stdy

This message was posted by a user wishing to remain anonymous

Hello,
My company is completing a hepatic impairment clinpharm study as a postmarketing requirement for our NDA and plans to submit a clinpharm labeling supplement to include recommended dose adjustment for mild, moderate, and severe hepatic impaired patients. We will have a complete clinpharm study report with datasets as well as clean and tracked changes PIs for our sNDA submission. For such a labeling sNDA, is any Module 2 clinical summary required? -- this is an oncology product.

Thank you for sharing your experience.