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This message was posted by a user wishing to remain anonymous

Hello - we have a clinical trial about to start under an open IND for a combination product (drug primary MOA).  There is a new(er) guidance document for postmarket safety reporting for combination products, but I can't find anything for premarket safety reporting for combination products.  I thought when I had researched this previously I found something saying that you report under the division you are under - i.e., under the drug SUSAR reporting guidelines and timelines, but I now can't find that reference any longer.  Can someone point me to FDA documentation where they mention this?

This message was posted by a user wishing to remain anonymous

Since the drug is under IND, all applicable safety reports  should be submitted to the IND. see the link below for IND safety reports:
https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-reporting-safety-reports

"All IND safety reports must be submitted on Form 3500A (if from clinical trials) or in a narrative format (if from animal or epidemiological studies) and be accompanied by Form 1571 (PDF - 830KB). The type of report (initial or follow-up) should be checked in the respective boxes on Forms 3500A and 1571. See Instructions for completing Form 3500A. 

The submission must be identified as:

• "IND safety report" for 15-day reports, or

• "7-day IND safety report" for unexpected fatal or life-threatening suspected adverse reaction reports, or

• "Follow-up IND safety report" for follow-up information................................."

Original Message:
Sent: 04-Oct-2022 10:43
From: Anonymous Member
Subject: combination safety reporting under IND

This message was posted by a user wishing to remain anonymous

Hello - we have a clinical trial about to start under an open IND for a combination product (drug primary MOA).  There is a new(er) guidance document for postmarket safety reporting for combination products, but I can't find anything for premarket safety reporting for combination products.  I thought when I had researched this previously I found something saying that you report under the division you are under - i.e., under the drug SUSAR reporting guidelines and timelines, but I now can't find that reference any longer.  Can someone point me to FDA documentation where they mention this?

Anonymous,

You are likely making reference to the relatively recent Postmarket Safety Reporting (PMSR) rule for combination products (21 CFR 4 subpart B), which has its own guidance document. I'll point you specifically to footnote 11 on page 8 of the guidance document which notes that investigational products are not subject to the PMSR rule, however if any constituent part (e.g. the device you may be using in your IND, if it is physically separate) is already marketed, then the reporting requirements apply.

The context of your situation will determine which requirements apply (or not), so feel free to reach out to me directly if you'd like to discuss further.

Best of luck!

------------------------------
Jonathan Amaya-Hodges
Director, Technical Services
Sharon MA
United States
------------------------------

Original Message:
Sent: 04-Oct-2022 10:43
From: Anonymous Member
Subject: combination safety reporting under IND

This message was posted by a user wishing to remain anonymous

Hello - we have a clinical trial about to start under an open IND for a combination product (drug primary MOA).  There is a new(er) guidance document for postmarket safety reporting for combination products, but I can't find anything for premarket safety reporting for combination products.  I thought when I had researched this previously I found something saying that you report under the division you are under - i.e., under the drug SUSAR reporting guidelines and timelines, but I now can't find that reference any longer.  Can someone point me to FDA documentation where they mention this?