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Federal Food Drug and Cosmetic Act (FFDCA) Proposed Rules Public Health

King & Spalding

LDT Final Rule: Shifting the LDT Battlefield

King & Spalding on

On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more

Akin Gump Strauss Hauer & Feld LLP

FDA’s Proposed Rule on Laboratory Developed Tests: One Small Change to Regulatory Language That Would Mark a Giant Leap in Lab...

On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more

Mintz - Health Care Viewpoints

Regulatory Roundup: Important FDA Developments at the End of September 2022

There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more

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