HP&M Attorney to Moderate FDLI Webinar on FDA’s (Emerging) Oversight of Laboratory-Developed Tests

On August 4, 2010, the Food and Drug Law Institute (“FDLI”) will host a webinar, titled “FDA’s (Emerging) Oversight of Laboratory-Developed Tests.”  Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs will moderate the webinar and a panel of speakers that includes FDA’s Elizabeth A. Mansfield, Ph.D., who is Director of Personalized Medicine in the Office of In Vitro Diagnostic Device Evaluation and Safety in the Center for Devices and Radiological Health.  Information about the webinar, including how to register, is available here.

As we recently reported, Laboratory-Developed Tests (“LDTs”) are a hot topic.  In July, FDA held a workshop, during which Agency officials stated that FDA plans to regulate some LDTs as medical devices, ending the enforcement discretion FDA has historically exercised over some LDTs.