NAVIGATING FDA OVERSIGHT OF LABORATORY DEVELOPED TESTS DURING AN ERA OF UNCERTAINTY

Laboratory-developed tests (LDTs) continue to thrive and play a critical role in clinical decision making and patient management, particularly in the personalized medicine environment. The FDA has historically followed a process of “enforcement discretion” in refraining from regulating LDTs until factors such as a changing marketplace and changing technology caused FDA to seek greater oversight. Under the proposed framework released in 2014, the FDA would exercise greater oversight of labs developing LDTs. However, these labs would still be subject to oversight by the Centers for Medicare and Medicaid Services (CMS), which currently regulates laboratories under the Clinical Laboratory Improvement Amendments (CLIA) program.

• Overview of key points in draft guidance and what industry needs to know
• Practical tips to manage risk
• Forecasting future regulatory developments

 

Speakers:
Elaine H. Tseng
Partner
King and Spalding

Lisa M. Dwyer
Partner
King and Spalding

Contact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693 | bakins@q1productions.com​