This is the most clean explanation of an EUA i ha
Post# of 155057
(Total Views: 439)
Posted On: 03/18/2021 11:02:15 AM
Re: ClosetInvestor #83409
This is the most clean explanation of an EUA i have found:
"Emergency Use Authorization (EUA)
An Emergency Use Authorization (EUA) is one of several tools the FDA is using to help make certain medical products available quickly during the COVID-19 pandemic. In certain emergencies, the FDA can issue an EUA to provide access to medical products that may potentially be used when there are no adequate, approved, and available options.
The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.
When evaluating an EUA, we carefully balance the potential risks and benefits of the products based on the data currently available.
EUAs are effective until the emergency declaration ends. EUAs can also be revised or revoked by the FDA at any time as we continue to evaluate the available data and patient needs during the public health emergency."
I think you are correct in saying a "conditional EUA" is an oxymoron, all EUAs have a criteria or condition to have them pulled. My guess is that is in reference to how an EUA is taken away, not a condition for how it becomes an approved drug?
https://www.fda.gov/consumers/consumer-update...s-covid-19
"Emergency Use Authorization (EUA)
An Emergency Use Authorization (EUA) is one of several tools the FDA is using to help make certain medical products available quickly during the COVID-19 pandemic. In certain emergencies, the FDA can issue an EUA to provide access to medical products that may potentially be used when there are no adequate, approved, and available options.
The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.
When evaluating an EUA, we carefully balance the potential risks and benefits of the products based on the data currently available.
EUAs are effective until the emergency declaration ends. EUAs can also be revised or revoked by the FDA at any time as we continue to evaluate the available data and patient needs during the public health emergency."
I think you are correct in saying a "conditional EUA" is an oxymoron, all EUAs have a criteria or condition to have them pulled. My guess is that is in reference to how an EUA is taken away, not a condition for how it becomes an approved drug?
https://www.fda.gov/consumers/consumer-update...s-covid-19
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