Short-sighted is what you get with information overload, and I would guess that's where FDA is now, so focused only on responses that are coming up in the the near future. Maybe once they come out the other side, they will have a chance to think more broadly, and issue another letter. Well, actually, even if they don't have a chance to think more broadly, once we all come out the other side, I have a feeling that there will be plenty of folks lining up to direct their attention that way. :)
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 25-Mar-2020 08:16
From: Ginger Cantor
Subject: FDA Review times and COVID-19
Beth,
That letter said the 60 days extension only applied if the response was due by April 30.
I am curious if this means they don't expect to extend that for responses due even months from the date of their letter (180 days) or 6 months from end of March. If testing labs and sponsors are short employees because of COVID-19, and thus are backed up now, there will be backlogs well into summer and fall would think.
Seems short-sighted to only extend for responses due by April 30.
Thoughts?
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
Original Message:
Sent: 24-Mar-2020 08:45
From: Beth Foster
Subject: FDA Review times and COVID-19
Never mind - I just saw the Letter to Industry granting anyone that has a marketing application currently on hold gets an extra 60 days.
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Beth Foster
Regulatory Affairs Manager
Miami Lakes FL
United States
Original Message:
Sent: 24-Mar-2020 08:42
From: Beth Foster
Subject: FDA Review times and COVID-19
We asked for an extension for our AI Response due to a delay in our testing. We just got granted an extra 60 days. Did anyone else receive information on extensions?
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Beth Foster
Regulatory Affairs Manager
Miami Lakes FL
United States
Original Message:
Sent: 16-Mar-2020 15:22
From: Anonymous Member
Subject: FDA Review times and COVID-19
This message was posted by a user wishing to remain anonymous
Does anyone know if FDA review times have been delayed due to COVID-19? Is this likely to happen? Thank you!