Lexology June 6, 2024
In this second installment of our nine-part deep-dive into the U.S. Food & Drug Administration (“FDA” or “the Agency”) final rule on Laboratory Developed Tests (“LDTs”) – which established a staged plan that will phase out the Agency’s previous policy of enforcement discretion for LDTs – we are taking a closer look at the response to the rule, not only from laboratories and other industry stakeholders but also from members of the legislature. The long and short of it is – people are not happy!
The highly anticipated final rule (which we covered in greater detail in our previous article) went into effect on May 6 and made two pivotal changes to the regulatory framework for LDTs. First, it amended...
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