Episode 132
The Long and Winding Road of Regulating Laboratory Developed Tests w/ Catherine Sharkey
August 18, 202315m 1s
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Show Notes
Health Affairs' Marianne Amoss interviews Catherine Sharkey from NYU School of Law to discuss regulations and patient safety regarding laboratory developed tests (LDT).
View Health Affairs' current Request for Abstracts.
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)
Topics
health policyhealth affairshealth inequitiesACAAffordable Care Actindividual mandateMedicareMedicaidCMSHHS