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

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)