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Changing Legal Environment Adds Uncertainty to ACLA Lawsuit Against FDA Over LDT Rule

Of Counsel Benjamin Zegarelli spoke with GenomeWeb about an ACLA lawsuit against the FDA in connection with its final rule on laboratory-developed tests.

Benjamin says, "My perspective on it is that the case for judicial deference to FDA under the current system without any changes would probably favor FDA's position to a certain extent. I'm not saying it would be a total slam dunk for FDA … but the idea would be that under normal circumstances, as we've seen in the current state of jurisprudence, we should see courts deferring to FDA."