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Posted On: 03/26/2021 10:46:55 PM
Post# of 153887
What timelines should you expect for the review process?
In a critical ongoing or imminent situation, the FDA aims to review EUAs within hours or days. For instance, the FDA issued EUAs for COVID-19 diagnostic tests to Roche, Thermo Fisher Scientific, and Abbott Laboratories within 24 hours of their request submissions.
However, the timeline for FDA action on an EUA request depends on several considerations, such as the regulatory history and profile of the product, the level of pre-EUA communication with the FDA, and the seriousness of the emergency.
It is important to realize that an EUA does not signify FDA approval, licensure, or clearance and is not an accepted endpoint for product development. In general, an EUA will remain in effect only for the duration of the EUA declaration under which it was issued. Sponsors should continue to develop their product, working towards FDA approval after the termination of the emergency. In fact, the FDA encourages Sponsors to design and conduct appropriately controlled clinical trials during the emergency response.
Author:
RAHUL CHANDRASEKHAR, PHD
Scientist, Regulatory Strategy
Camargo
Source: https://camargopharma.com/resources/blog/emer...t-qualify/
https://www.linkedin.com/in/rahulchandrasekhar/
I am sending him a message asking his opinion
In a critical ongoing or imminent situation, the FDA aims to review EUAs within hours or days. For instance, the FDA issued EUAs for COVID-19 diagnostic tests to Roche, Thermo Fisher Scientific, and Abbott Laboratories within 24 hours of their request submissions.
However, the timeline for FDA action on an EUA request depends on several considerations, such as the regulatory history and profile of the product, the level of pre-EUA communication with the FDA, and the seriousness of the emergency.
It is important to realize that an EUA does not signify FDA approval, licensure, or clearance and is not an accepted endpoint for product development. In general, an EUA will remain in effect only for the duration of the EUA declaration under which it was issued. Sponsors should continue to develop their product, working towards FDA approval after the termination of the emergency. In fact, the FDA encourages Sponsors to design and conduct appropriately controlled clinical trials during the emergency response.
Author:
RAHUL CHANDRASEKHAR, PHD
Scientist, Regulatory Strategy
Camargo
Source: https://camargopharma.com/resources/blog/emer...t-qualify/
https://www.linkedin.com/in/rahulchandrasekhar/
I am sending him a message asking his opinion
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