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Laboratories Clinical Laboratories Food and Drug Administration (FDA)

Robinson+Cole Health Law Diagnosis

FDA Sued Over Laboratory Developed Tests Final Rule

The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same preapproval and...more

Foley & Lardner LLP

Is Next Generation Sequencing Ready for Personalized Medicine?

Foley & Lardner LLP on

Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more

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