Webinar: The Future of LDT Oversight- April 22, 2015
March 30, 2015In October 2014, the FDA published draft guidance outlining how the agency plans to regulate laboratory developed tests (LDTs) using a risk-based approach that, if implemented, would have significant implications for clinical laboratories. Since the release of the draft guidance, numerous stakeholders—ranging from clinicians and hospitals to commercial laboratories and disease-specific advocacy groups—have expressed concerns about the agency’s proposed approach to LDT regulation, and have recommended substantial changes. Some have even hinted at potential legal action and possible congressional involvement. What do these recent developments mean for the future of LDT oversight? Join the AACC for this 60-minute webinar and get the most up-to-date information on the LDT regulatory policy issues of concern to the health care community. You will also learn about the legal and political forces that may shape the outcome of this debate.