Pluto, my dealings with the FDA were limited and n
Post# of 11803
(Total Views: 333)
Posted On: 04/12/2020 1:04:41 PM
Re: Bialystock #9743
Pluto, my dealings with the FDA were limited and not complicated. I hope there are options in this situation which ultimately shine light on a major breakthrough.
I do not believe that DECN is a part of the current FDA antibody-antigen embargo. DECN's issues with the FDA will be to determine which tests the FDA is expecting are applicable. For example, you cannot test for reagent contamination if your product doesn't use reagents. You cannot test for sample transit contamination if your sample doesn't transit. The EUA group at the FDA was brought in from several disciplines because they were the "get things done" people. This does not mean these same people are the best scientists at the FDA. KB's job is to educate these people.
I do not believe that DECN is a part of the current FDA antibody-antigen embargo. DECN's issues with the FDA will be to determine which tests the FDA is expecting are applicable. For example, you cannot test for reagent contamination if your product doesn't use reagents. You cannot test for sample transit contamination if your sample doesn't transit. The EUA group at the FDA was brought in from several disciplines because they were the "get things done" people. This does not mean these same people are the best scientists at the FDA. KB's job is to educate these people.
(1)
(0)