A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?
FDA Law Blog: Biosimilars
NOVEMBER 1, 2023
FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. FDA’s position is, however, only one side of the story. Specific features of the PR will foreseeably yield new bases for challenge.
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