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Thursday, September 02, 2021 3:55:53 PM
Suggest you look under what is considered by the FDA, to prove safety & efficacy for an EUA and you will find that clinical trial evidence is not mentioned. There are many ways, and they list them, to show efficacy and safety for an EUA besides clinical trial.
Are you confusing the EUA pathway with the full approval pathway?
Suggest you look at my past posts where I noted this difference or do your own legwork on the FDA website.
You guys at like a tag team.
Your links don't even prove your point, but I think you knew that.
Message in reply to:
"Can you prove there have been no EUA awards for trials under 121?"
Yes:
Vaccines:
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines
Therapeutics:
https://www.fda.gov/media/136832/download
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