TAG:
Food Drug and Cosmetic Act
ACLA Files Court Challenge to FDA’s Final LDT Rule
CEO SUMMARY: Discussing the FDA’s final LDT rule, one pathologist tracking this matter wrote, “In many ways, the FDA’s plan [final LDT rule] is like the guy who gets three wishes from a genie, and he asks for unlimited wishes.” ACLA and HealthTrackRx are challenging the FDA’s …
ACLA President Van Meter Discusses LDT Lawsuit
CEO SUMMARY: On July 5, the final laboratory developed test (LDT) rule issued by the federal Food and Drug Administration (FDA) takes effect. In response, the American Clinical Laboratory Association (ACLA) filed a lawsuit in federal court in Texas to challenge the FDA’s actions. In thi…
Attorneys Assess Impact of FDA’s Final LDT Rule
CEO SUMMARY: Publication of the Food and Drug Administration’s final rule on laboratory developed tests (LDTs) is already causing some labs to consider withdrawing their existing LDTs because of compliance costs. Two experienced lab industry attorneys discuss aspects of the LDT rule and…
Congressional Subcommittee Hears Testimony on FDA LDT Rule
DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommitt…
CMS Issues AI Guidance for Medicare Advantage
CEO SUMMARY: With its guidance on how Medicare Advantage plans should use artificial intelligence (AI) when making treatment decisions involving individual patients, the federal Centers for Medicare and Medicaid Services has opened one door in the coming debate on how the federal governme…
FDA Expected to Publish Proposed LDT Rule in August
CEO SUMMARY: Congressional lawmakers and the federal Food and Drug Administration are again eyeing changes that would bring greater oversight to laboratory-developed tests (LDTs). Leaders at clinical laboratories and pathology groups should monitor these proposals, both of which c…
CURRENT ISSUE
Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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