Key stakeholders weigh in on FDA’s Laboratory Developed Test Rule. They don’t like what they see.

The 60-day comment period on the FDA’s proposed rule to revamp the way that laboratory developed tests (LDTs) are regulated ended on December 4th, 2023. Based on AgencyIQ’s review of available comments, it’s clear that key stakeholders are generally opposed to the rule for a wide range of significant reasons. We have some high-level takeaways for our readers in the piece below.

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