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Final Rules Medical Devices 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 Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products

Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more

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