FDA Regulation of Laboratory-Developed Tests: What to Expect, How to Prepare




This G2 Intelligence Webinar presented by Mahnu Davar and Jen Madsen of Arnold & Porter’s Life Sciences and Healthcare Regulatory Practice.

Mahnu Davar

Arnold & Porter LLP
Jen Madsen
Health Policy Advisor

Arnold & Porter LLP
Duration: 90 minutes

The U.S. Food Drug & Administration (FDA) is poised to reverse its longstanding policy of exercising “enforcement discretion” … and will soon regulate laboratory-developed tests (LDTs) … YOUR LAB MUST BE PREPARED.

Learn How New FDA Regulations for LDTs Will Affect Lab Operations … and Your Bottom Line

The FDA is on the brink of regulating LDTs … and the anticipated effects of FDA regulation will be profound … IS YOUR LAB READY?

Join health care industry experts Mahnu Davar and Jen Madsen of Arnold & Porter to discover the impact reversal of “enforcement discretion” will have … what to expect during an FDA Inspection … and practical steps you can take now to prepare.

This 90-minute webinar will take a deep look at the impact on lab operations … the implications for fraud and abuse laws … compliance program design … reimbursement strategy … and the overall effect on your laboratory operations. This webinar will review and discuss:

  • The implications of FDA regulations on the future of LDTs – and the impact in your lab.
  • Practical steps you need to take NOW to prepare for FDA regulation.
  • The impact on regulatory and policy issues including fraud and abuse laws, compliance program design, and reimbursement strategy.
  • And much, much more!

Make no mistake the strategies provided by Mahnu Davar and Jen Madsen in this valuable 90-minute webinar can help you Understand the Impact of FDA regulation on your Laboratory’s Operations… and Bottom Line.

To register, please click the Register Now button above.
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About Your Presenters
Mahnu Davar
Partner, Arnold & Porter LLP
As a Partner in Arnold & Porter’s Life Sciences and Healthcare Regulatory Practice, Mahnu Davar helps clients to navigate FDA and healthcare regulations, build and enhance their compliance programs, conduct internal audits and investigations, and represents them in government inspections and investigations. He has represented early- stage medical technology companies, clinical labs, major research universities, and some of the largest multinational drug and device companies in the oncology, ophthalmology, pain, and diabetes care spaces.
Jen Madsen, MPH
Health Policy Advisor, Arnold & Porter LLP
Jen Madsen is a Health Policy Advisor in Arnold & Porter’s Life Sciences and Healthcare Regulatory Practice and its Legislative and Public Policy Practice. She advises clients on payer coverage and reimbursement policy, and on FDA and CLIA regulatory policy. As a registered lobbyist, Jen advocates on her clients’ behalf to the U.S. Congress and Executive Branch agencies. She has represented the Personalized Medicine Coalition, the American Clinical Laboratory Association, the College of American Pathologists, and clients in the diagnostics and biopharmaceutical industries.