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Personalized Medicine Food and Drug Administration (FDA) 510(k) RTA

Foley & Lardner LLP

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

Foley & Lardner LLP on

Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

Foley & Lardner LLP

Considering Sex-Specific Variation for Personalized Medicine

Foley & Lardner LLP on

Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more

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