Government oversight of clinical laboratories continues to be a volatile subject matter. For example, health care practitioners are more frequently using laboratory developed tests (LDTs) to diagnose and predict the risk of developing a disease, as well as to inform decisions on disease-state management such as for cancer, heart disease, and diabetes. As practitioners become increasingly reliant on diagnostic tests to guide important treatment decisions, concerns about the efficacy and safety of new LDTs have simultaneously arisen. Accordingly, the opportunity for clinical laboratories to commercialize their products and services continues to expand in an evolving regulatory landscape.

Please join us for a panel discussion regarding the past, present, and future government regulation and enforcement of clinical laboratories. Our panelists will focus on the development of new rules and regulations applicable to clinical laboratories as well as potential governmental enforcement trends. We will focus on proposed FDA regulations that may impact clinical laboratories as well use case studies to discuss how governmental agencies may pursue enforcement actions against clinical laboratories.

Date & TIme

Thursday, May 26, 2016
12:00 PM - 1:00 PM ET


John Devine
Health Care


Beth Moskow-Schnoll
White Collar Defense/Internal Investigations

Neil P. DiSpirito
Life Sciences and Technology

This program is open to Ballard Spahr clients and prospective clients interested in government regulation and enforcement of clinical laboratories. There is no cost to attend. This program is not eligible for CLE credits.

Please register at least two days before the webinar. Login details will be sent to all approved registrants. For more information, contact Lisa M. Prickril at