Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello all, 
Our small company recently received a report of an Adverse Event that was reported to FDA via the MedWatch telephone number 1-800-FDA-1088. 
(this was actually the first case we have received  directly from the FDA.) 
We reviewed the report, and performed both an Adverse Event analysis and a Product Quality Complaint investigation as we typically do when we receive a report directly via our PV intake group. 
The investigations indicated that the event was non-serious, and no Field Alert or recall or any other action was required. 
The MedWatch letter states "results of any actions taken by your firm because of the report(s) should be forwarded to" the FDA.
Is this interpreted to mean we need to send the copies of our investigation reports back to the FDA, or does this mean we would only need to send back information about any recall or safety actions taken as a result of our investigations?

Any clarification based on your experience would be most helpful!

Hello Anonymous,

Aha, welcome to 45 day letters!  In this case, you should reply to FDA by letter summarizing that you did investigate this in accordance with your PV procedures, and give at least some detail of what you found. State in the letter whether (or not) the reporter also informed you of the incident.  You should always reply.

Consider how much detailed  information you give. Some may be helpful, but they have to review all you give; ... too much, if not well organized could trigger an unneeded back and forth dialogue, especially if it was non-serious and no adverse safety or quality trends are evident from your point of view.

The point is to give a snapshot, categorize why you believe it was non-serious, and why if it happened again whether there would be a serious event. Reiterate your PV systems. Confirm you did not take any other actions before this report from FDA related to this event or similar ones- it is not related to recalls, fixes, trends?  (And maybe thank them for bringing this to your attention).

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 19-Jun-2019 16:42
From: Anonymous Member
Subject: required response to MedWatch report?

This message was posted by a user wishing to remain anonymous

Hello all,
Our small company recently received a report of an Adverse Event that was reported to FDA via the MedWatch telephone number 1-800-FDA-1088.
(this was actually the first case we have received  directly from the FDA.)
We reviewed the report, and performed both an Adverse Event analysis and a Product Quality Complaint investigation as we typically do when we receive a report directly via our PV intake group.
The investigations indicated that the event was non-serious, and no Field Alert or recall or any other action was required.
The MedWatch letter states "results of any actions taken by your firm because of the report(s) should be forwarded to" the FDA.
Is this interpreted to mean we need to send the copies of our investigation reports back to the FDA, or does this mean we would only need to send back information about any recall or safety actions taken as a result of our investigations?

Any clarification based on your experience would be most helpful!

Hello Anonymous,

Aha, welcome to 45 day letters!  In this case, you should reply to FDA by letter summarizing that you did investigate this in accordance with your PV procedures, and give at least some detail of what you found. State in the letter whether (or not) the reporter also informed you of the incident.  You should always reply.

Consider how much detailed  information you give. Some may be helpful, but they have to review all you give; ... too much, if not well organized could trigger an unneeded back and forth dialogue, especially if it was non-serious and no adverse safety or quality trends are evident from your point of view.

The point is to give a snapshot, categorize why you believe it was non-serious, and why if it happened again whether there would be a serious event. Reiterate your PV systems. Confirm you did not take any other actions before this report from FDA related to this event or similar ones- it is not related to recalls, fixes, trends?  (And maybe thank them for bringing this to your attention).

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 19-Jun-2019 16:42
From: Anonymous Member
Subject: required response to MedWatch report?

This message was posted by a user wishing to remain anonymous

Hello all,
Our small company recently received a report of an Adverse Event that was reported to FDA via the MedWatch telephone number 1-800-FDA-1088.
(this was actually the first case we have received  directly from the FDA.)
We reviewed the report, and performed both an Adverse Event analysis and a Product Quality Complaint investigation as we typically do when we receive a report directly via our PV intake group.
The investigations indicated that the event was non-serious, and no Field Alert or recall or any other action was required.
The MedWatch letter states "results of any actions taken by your firm because of the report(s) should be forwarded to" the FDA.
Is this interpreted to mean we need to send the copies of our investigation reports back to the FDA, or does this mean we would only need to send back information about any recall or safety actions taken as a result of our investigations?

Any clarification based on your experience would be most helpful!

This message was posted by a user wishing to remain anonymous

​I wasn't clear on the source... Was this a 45-day letter (message from FDA requesting a response), or was it the MedWatch-To-Manufacturer program (just a copy of a form 3500, with advice to file an MDR if required)?
Original Message:
Sent: 21-Jun-2019 08:12
From: Ginger Cantor
Subject: required response to MedWatch report?

Hello Anonymous,

Aha, welcome to 45 day letters!  In this case, you should reply to FDA by letter summarizing that you did investigate this in accordance with your PV procedures, and give at least some detail of what you found. State in the letter whether (or not) the reporter also informed you of the incident.  You should always reply.

Consider how much detailed  information you give. Some may be helpful, but they have to review all you give; ... too much, if not well organized could trigger an unneeded back and forth dialogue, especially if it was non-serious and no adverse safety or quality trends are evident from your point of view.

The point is to give a snapshot, categorize why you believe it was non-serious, and why if it happened again whether there would be a serious event. Reiterate your PV systems. Confirm you did not take any other actions before this report from FDA related to this event or similar ones- it is not related to recalls, fixes, trends?  (And maybe thank them for bringing this to your attention).

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 19-Jun-2019 16:42
From: Anonymous Member
Subject: required response to MedWatch report?

This message was posted by a user wishing to remain anonymous

Hello all,
Our small company recently received a report of an Adverse Event that was reported to FDA via the MedWatch telephone number 1-800-FDA-1088.
(this was actually the first case we have received  directly from the FDA.)
We reviewed the report, and performed both an Adverse Event analysis and a Product Quality Complaint investigation as we typically do when we receive a report directly via our PV intake group.
The investigations indicated that the event was non-serious, and no Field Alert or recall or any other action was required.
The MedWatch letter states "results of any actions taken by your firm because of the report(s) should be forwarded to" the FDA.
Is this interpreted to mean we need to send the copies of our investigation reports back to the FDA, or does this mean we would only need to send back information about any recall or safety actions taken as a result of our investigations?

Any clarification based on your experience would be most helpful!

This message was posted by a user wishing to remain anonymous

Thank you for your responses.
It was just a standard Medwatch to manufacturer report with an MSB reference number. It was not either a form 3500 or a 45 day letter. 
In the text of the cover letter, the last line stated "If you have questions, we may be contacted at 301-796-3140. Results of any actions taken by your firm because of the report(s) should be forwarded to: FDA, CDER, Office of Compliance, Office of Manufacturing and Product Quality, Drug Surveillance and Data Reporting Branch, email: CDERDQRSREPORTS@fda.hhs.gov"
Original Message:
Sent: 22-Jun-2019 15:50
From: Anonymous Member
Subject: required response to MedWatch report?

This message was posted by a user wishing to remain anonymous

​I wasn't clear on the source... Was this a 45-day letter (message from FDA requesting a response), or was it the MedWatch-To-Manufacturer program (just a copy of a form 3500, with advice to file an MDR if required)?
Original Message:
Sent: 21-Jun-2019 08:12
From: Ginger Cantor
Subject: required response to MedWatch report?

Hello Anonymous,

Aha, welcome to 45 day letters!  In this case, you should reply to FDA by letter summarizing that you did investigate this in accordance with your PV procedures, and give at least some detail of what you found. State in the letter whether (or not) the reporter also informed you of the incident.  You should always reply.

Consider how much detailed  information you give. Some may be helpful, but they have to review all you give; ... too much, if not well organized could trigger an unneeded back and forth dialogue, especially if it was non-serious and no adverse safety or quality trends are evident from your point of view.

The point is to give a snapshot, categorize why you believe it was non-serious, and why if it happened again whether there would be a serious event. Reiterate your PV systems. Confirm you did not take any other actions before this report from FDA related to this event or similar ones- it is not related to recalls, fixes, trends?  (And maybe thank them for bringing this to your attention).

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 19-Jun-2019 16:42
From: Anonymous Member
Subject: required response to MedWatch report?

This message was posted by a user wishing to remain anonymous

Hello all,
Our small company recently received a report of an Adverse Event that was reported to FDA via the MedWatch telephone number 1-800-FDA-1088.
(this was actually the first case we have received  directly from the FDA.)
We reviewed the report, and performed both an Adverse Event analysis and a Product Quality Complaint investigation as we typically do when we receive a report directly via our PV intake group.
The investigations indicated that the event was non-serious, and no Field Alert or recall or any other action was required.
The MedWatch letter states "results of any actions taken by your firm because of the report(s) should be forwarded to" the FDA.
Is this interpreted to mean we need to send the copies of our investigation reports back to the FDA, or does this mean we would only need to send back information about any recall or safety actions taken as a result of our investigations?

Any clarification based on your experience would be most helpful!