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

<p><em>Health Affairs</em>' Marianne Amoss interviews Catherine Sharkey from NYU School of Law to discuss regulations and patient safety regarding laboratory developed tests (LDT).</p><p><a href="https://www.healthaffairs.org/request-for-abstracts?utm_medium=podcast&amp;utm_source=this+week">View <em>Health Affairs</em>' current Request for Abstracts.</a></p><p><strong>Related Links:</strong></p><ul> <li> <a href="https://www.healthaffairs.org/content/forefront/7-3-o-mahony-piece?utm_medium=podcast&amp;utm_source=this+week">To Protect Patients And Spark Innovation, Codify The FDA’s Oversight Of Laboratory-Developed Tests</a> (<em>Health Affairs Forefront</em>)</li> <li> <a href="https://www.nytimes.com/2022/04/20/upshot/prenatal-genetic-tests-warning.html">F.D.A. Warns Patients About Some Prenatal Genetic Tests</a> (<em>New York Times</em>)</li> <li> <a href="https://www.nytimes.com/2023/06/27/upshot/prenatal-testing-misleading-fda.html">F.D.A. Wants to Regulate Prenatal Tests That Have Misled Parents</a> (<em>New York Times</em>)</li> <li> <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4108202">Direct-to-Consumer Genetic Testing: The FDA's Dual Role as Safety and Health Information Regulator</a> (<em>DePaul Law Review</em>)</li> <li> <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4108020">Regulatory and Medical Aspects of DTC Genetic Testing</a> (<em>Consumer Genetic Technologies: Ethical and Legal Considerations</em>)</li> </ul>