Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,  If a study is being conducted under an FDA IND, and a Dear Investigator Letter is distributed that outlines side effects that change the risk/benefit ratio, could lead to disability, and certainly would impact the patient's willingness to participate, does study enrollment need to be suspended until the FDA is notified and responds?

This message was posted by a user wishing to remain anonymous

Regardless, you must notify the FDA ASAP! And outline your action plan i.e. update IB, amendment to the IND on protocol changes, and any other safety measures as well as justification for the patient in order to continue the enrollment and at modified or unmodified dosing etc.....................Else, the FDA will put a clinical hold!
Original Message:
Sent: 01-Dec-2022 14:57
From: Anonymous Member
Subject: Dear Investigator Letter for IND Study

This message was posted by a user wishing to remain anonymous

Hi All,  If a study is being conducted under an FDA IND, and a Dear Investigator Letter is distributed that outlines side effects that change the risk/benefit ratio, could lead to disability, and certainly would impact the patient's willingness to participate, does study enrollment need to be suspended until the FDA is notified and responds?

If new safety information has been identified that warrants a Dear Investigator Letter and FDA is not already notified, that is a significant issue and should be remedied. If there is not a specific case to report a safety report is still appropriate. Depending on the seriousness, it may warrant a phone call. From your comment, it sounds like you have identified a significant risk and the response should be appropriate to the risk. Without further detail is difficult to say whether enrolment needs to be suspended.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 01-Dec-2022 14:57
From: Anonymous Member
Subject: Dear Investigator Letter for IND Study

This message was posted by a user wishing to remain anonymous

Hi All,  If a study is being conducted under an FDA IND, and a Dear Investigator Letter is distributed that outlines side effects that change the risk/benefit ratio, could lead to disability, and certainly would impact the patient's willingness to participate, does study enrollment need to be suspended until the FDA is notified and responds?