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Diagnostic Tests Rulemaking Process Food and Drug Administration (FDA)

Polsinelli

Challenges to LDT Final Rule Continue as Rule Goes into Effect

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As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more

Foley & Lardner LLP

FDA Considering New Regulatory Approaches for NGS – Part II

Foley & Lardner LLP on

The Food and Drug Administration (“FDA”) announced a workshop to be held February 20th, 2015, entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” to obtain public input regarding...more

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