Section E of the FDA December 2015 Draft Guidance
Safety Assessment for IND Safety Reporting may help you answer your question. It defines "relevant follow-up information" and non-relevant information that should be submitted as soon as available. For an individual Safety Report relevant information is "(1) a change in diagnosis of the adverse event, (2) death as a result of the adverse event, (3) autopsy findings, and (4) other new information that significantly impacts the assessment of causality." If the information does not meet these criteria, a follow-up report may not be required, but good practice is to submit a follow-up that closes out the report.
Health Canada has these different instructions, which seems to be what you reference as an "8-day" follow-up report: "
Where it is fatal or life-threatening, within 7 days after becoming aware of the information. Within 8 days after having initially informed Health Canada of the fatal or life-threatening ADR, submit as complete a report as possible. Follow-up reports of fatal or life-threatening reactions must include an assessment of the importance and implication of the findings, including relevant previous experience with the same or similar drugs." For information obtained a month later, I would follow the same practice as for the FDA.------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 19-Dec-2019 10:25
From: Marianne Lenton
Subject: Timing for Susar Reports
Thank you very much for your response. However, could you kindly address the following question?
Hypothetical Question: An initial report is received for a Phase III Clinical Trial. The event is a Life-Threatening SUSAR event (study product is a drug, not a medical device or combination product, etc.). The report is submitted within the 7-day reporting period to the FDA and Health Canada. A follow-up report is not provided in the following 8-day period. However, one full month later, a follow-up report is provided and the question centers on the reporting timeframe. Should this follow-up report be considered an "8-day" follow-up report – or should it now be considered a 15-day follow-up report to Health Canada and the FDA? And should all subsequent follow-up reports be considered 15-day reports?
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Marianne Lenton
Senior Safety Scientist
Philadelphia PA
United States
Original Message:
Sent: 18-Dec-2019 18:30
From: Anne LeBlanc
Subject: Timing for Susar Reports
Is that United States FDA? For a clinical trial? For a drug?
Per Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies:
"Any relevant additional information that the sponsor obtains that pertains to a previously submitted IND safety report must be submitted as a Followup IND Safety Report without delay, as soon as the information is available (21 CFR 312.32(d)(2))."
https://www.fda.gov/media/79394/download
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Anne LeBlanc
Manager, Regulatory Affairs
United States
Original Message:
Sent: 18-Dec-2019 16:52
From: Anonymous Member
Subject: Timing for Susar Reports
This message was posted by a user wishing to remain anonymous
The requirement for reporting any unexpected fatal or life-threatening suspected adverse reaction to FDA is no later than 7 calendar days after the sponsor's initial receipt of the information.
If follow-up safety information is received on the case but is after 8 days of submission of the initial case, is the follow-up due in 15 days or again in 7 days? Could someone kindly confirm this understanding? Many thanks!