Navigating FDA Oversight of Laboratory Developed Tests During an Era of Uncertainty

1 Hour Video | Elaine H. Tseng, Lisa M. Dwyer, King and Spalding

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  • Overview of key points in draft guidance and what industry needs to know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

 

 

Participants that will find this webinar most beneficial will be those involved in diagnostic companies.  Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Legal Counsel

 

tseng-elaine
Elaine H. Tseng
Partner
King  and  Spalding

Elaine Tseng is a partner with King and Spalding’s FDA and Life Sciences Practice Group. After prior practice with the group as an associate and partner-elect, Ms. Tseng rejoined the group following service as Regulatory Counsel at the Food and Drug Administration, where she received the Department of Health and Human Services Secretary’s Award for Distinguished Service and other FDA honors. In her practice, Ms. Tseng advises medical device, pharmaceutical, and biotechnology companies on a variety of FDA approval, compliance, and enforcement matters.

Ms. Tseng has been invited to speak on topics of FDA regulation for groups including the American Conference Institute (ACI), the Advanced Medical Technology Association (AdvaMed), the Biotechnology Industry Organization (BIO), and the Center for Business Intelligence (CBI). She received her law degree from Harvard Law School and her undergraduate degrees from Cornell University.

Dwyer-Lisa
Lisa M. Dwyer
Partner
King and Spalding

Lisa M. Dwyer is a partner in King and Spalding’s Washington, D.C. office and a member of the FDA and Life Sciences practice group. Lisa has more than 15 years experience working with legal and policy matters involving all FDA-regulated products. From 2010-2015, she served in the Commissioner’s Office at FDA as a Senior Policy Advisor, in the Office of Policy, and as the Deputy Chief of Staff to the Commissioner of Food and Drugs.

In these roles, Lisa provided strategic counseling to FDA’s Commissioner and other senior leadership on the agency’s most significant and complex issues, including: off-label marketing, oversight of laboratory developed tests (LDTs), oversight of next generation sequencing LDTs/in vitro diagnostics (part of President Obama’s Precision Medicine Initiative), advancing antimicrobial drug development and use, modernizing the legislative framework for cosmetics (including user fees), public-private partnerships, menu labeling, implementation of the Family Smoking Prevention and Tobacco Control Act of 2009, opioid misuse and abuse, and the Commissioner’s Transparency Initiative. In addition, she often served as a liaison for the FDA or worked closely with other parts of the federal government, including the Department of Health and Human Services, the National Institutes of Health, the Centers for Disease Control and Prevention, the Drug Enforcement Administration, and Congress.


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