A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?
FDA Law
NOVEMBER 1, 2023
Counterarguments abound, many of which were detailed in 2015 in a publication by counsel for the American Clinical Laboratory Association ( here ). FDA’s position is, however, only one side of the story. Even so, the entry of a stay pending final judgment may not be sufficient to immunize parties who rely on LDTs from the PR’s consequences.
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