Here’s a simple metaphor to illustrate the difference, if we’re going to argue the meaning of terms of art by their dictionary definitions.
When Sully Sullenberger pulled off the Miracle on the Hudson, that was an emergency use of the airplane’s water landing capability.
It wasn’t experimental. Airbus designed a “ditching” button for the A320, they knew more or less what it would do, and the regulators (here the FAA) agreed that having such a capability was less risky than not having it, even if it wasn’t vetted and maintained at the same level of rigor as, e.g., the landing gear.
Therefore something can be “emergency use” without being “experimental”, even if we stick to the simple common meaning of both terms.
You are downplaying the role of an emergency use authorization. "Reasonable belief" sounds experimental to me. Otherwise they would've had all the information needed for FDA approval, it wouldn't have been predicated on belief, and it wouldn't have been labeled emergency use.
Why are you so adverse to accepting the reality of the situation?
"The process for issuing an EUA is different than an FDA approval. Under an EUA, the FDA authorizes uses of medical products based on a reasonable belief that the product may be effective based on the best evidence available at the time, without waiting for all the information that would be needed for an FDA approval."[1]
thebooktocome|2 years ago
When Sully Sullenberger pulled off the Miracle on the Hudson, that was an emergency use of the airplane’s water landing capability.
It wasn’t experimental. Airbus designed a “ditching” button for the A320, they knew more or less what it would do, and the regulators (here the FAA) agreed that having such a capability was less risky than not having it, even if it wasn’t vetted and maintained at the same level of rigor as, e.g., the landing gear.
Therefore something can be “emergency use” without being “experimental”, even if we stick to the simple common meaning of both terms.
baremetal|2 years ago
Why are you so adverse to accepting the reality of the situation?
"The process for issuing an EUA is different than an FDA approval. Under an EUA, the FDA authorizes uses of medical products based on a reasonable belief that the product may be effective based on the best evidence available at the time, without waiting for all the information that would be needed for an FDA approval."[1]
[1] https://www.fda.gov/consumers/consumer-updates/understanding...
unknown|2 years ago
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