I think the FDA guidance possibly was misunderstoo
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Posted On: 04/10/2020 11:18:53 AM
I think the FDA guidance possibly was misunderstood by many insofar that the FDA was giving an open checkbook to companies, they weren't.
Not totally true. If your kit is a direct DNA type test, you get a blank check, provided you fill out the application correctly. If you have an antibody or antigen method, so far your chances of getting through the FDA review process are 1 in 70+. Not good odds and certainly not a blank check. And this is one of the major reasons why Scott Gottleib left as Trump's FDA Commissioner. He was unable to change the culture in the FDA Center. And, I have also begun to hear rumors that FDA UEA staff has begun to deliberately bed-bug applications, without reviewing them, because they are objecting to working 6 days a week. That is exactly the self-entitled behavior that supposedly lead to Gottleib's departure.
Not totally true. If your kit is a direct DNA type test, you get a blank check, provided you fill out the application correctly. If you have an antibody or antigen method, so far your chances of getting through the FDA review process are 1 in 70+. Not good odds and certainly not a blank check. And this is one of the major reasons why Scott Gottleib left as Trump's FDA Commissioner. He was unable to change the culture in the FDA Center. And, I have also begun to hear rumors that FDA UEA staff has begun to deliberately bed-bug applications, without reviewing them, because they are objecting to working 6 days a week. That is exactly the self-entitled behavior that supposedly lead to Gottleib's departure.
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