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Wednesday, April 07, 2021 8:25:19 PM
They could also get pretty specific with instructions. For example, they could tell the lower court that it should disregard a government agency's guidance as a matter of law.
Guidances “do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.”
The Apellate Court could also ask the lower court to determine if the FDA's approach to regulating stem cell treatments is arbitrary when comparing it to similar accepted procedures such as extracting blood, removing plasma, and then replacing the blood back into the body.
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