Short term, I agree the new site could be filed as an alternate - the risk is that if the original lab is listed in the filing, and any issues are discovered at the lab or the lab goes out of business, there may be issues. If this is a product you plan to continue to support/market for some time, it might be a great opportunity to file a new "baseline" submission, and bring the filing into the electronic age. Good luck!
Cathy
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Catherine Anderson PhD, RAC
Senior Manager - Regulatory CMC
Hillsborough NC
United States
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Original Message:
Sent: 21-Aug-2018 12:45
From: Anonymous Member
Subject: Change of Contract Laboratory with FDA
This message was posted by a user wishing to remain anonymous
It will be tricky to mention (unsure) contract testing site in your submission. As of now the best route I can think of is to submit the new contract lab site as an alternative in your supplement.
Original Message:
Sent: 21-Aug-2018 04:51
From: Anonymous Member
Subject: Change of Contract Laboratory with FDA
This message was posted by a user wishing to remain anonymous
Great - thank you for the direction!
Original Message:
Sent: 07-Aug-2018 11:58
From: Ruth Collins
Subject: Change of Contract Laboratory with FDA
You could use the PAC-ATLS guidance to add a laboratory.
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Ruth Collins RAC
Manager Regulatory Affairs
Euless TX
United States
Original Message:
Sent: 26-Jul-2018 07:21
From: Anonymous Member
Subject: Change of Contract Laboratory with FDA
This message was posted by a user wishing to remain anonymous
Hello!
Does anyone know if it's possible to change contract laboratory mentioned (or not) in an original NDA? We have a very very old paper NDA and can't find the mention of this lab. We want to change lab but we are not sure it even was ever mentioned in the NDA. What would be the best route to go about this?
Thanks in advance for your help!