A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?
FDA Law Blog
NOVEMBER 1, 2023
Conspicuously missing is any rebuttal to one other issue raised in the June 22, 2020 HHS memo : that laboratories based out of state universities or public health departments are not “persons” as defined in key premarket review and enforcement provisions of the FD&C Act.
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