The Long and Winding Road of Regulating Laboratory Developed Tests w/ Catherine Sharkey

Health Affairs This Week

Health Affairs' Marianne Amoss interviews Catherine Sharkey from NYU School of Law to discuss regulations and patient safety regarding laboratory developed tests (LDT).

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Related Links:

• To Protect Patients And Spark Innovation, Codify The FDA’s Oversight Of Laboratory-Developed Tests (Health Affairs Forefront)
• F.D.A. Warns Patients About Some Prenatal Genetic Tests (New York Times)
• F.D.A. Wants to Regulate Prenatal Tests That Have Misled Parents (New York Times)
• Direct-to-Consumer Genetic Testing: The FDA's Dual Role as Safety and Health Information Regulator (DePaul Law Review)
• Regulatory and Medical Aspects of DTC Genetic Testing (Consumer Genetic Technologies: Ethical and Legal Considerations)

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