In this installment of Medmarc’s webinar series, Kate Klaus, an attorney and FDA specialist in our Risk Management department, will guide a discussion of the top life sciences news stories of the past year and their potential implications for products liability. Topics will include:
- The dramatic impact of COVID-19 and the life sciences industry’s response to the pandemic;
- Changes at FDA driven by the COVID-19 pandemic and their impact on the industry; and
- How potential changes in leadership at the Department of Health and Human Services and FDA may shape the coming year.
Kathryn Klaus, Esq. is a Risk Management Attorney, FDA Specialist. Her focus is on legal matters faced by participants in the life sciences industry, specifically FDA regulatory compliance. She began her career with FDA’s Center for Biologics Evaluation and Research, where she worked on the Broad Spectrum Autism litigation under the National Childhood Vaccine Injury Act.
After leaving FDA, Ms. Klaus worked in private practice with two national law firms, counseling clients through all phases of the regulated product life cycle, including development and approval, manufacturing, labeling and advertising, and post-market concerns and enforcement. She has advised clients regarding defense against regulatory enforcement actions, including FDA 483 Inspectional Observations, Warning Letters, U.S. Customs detentions, product recalls, and DHHS OIG exclusion proceedings. She has also counseled clients through all health law-related aspects of major transactions, from conducting facility and records compliance auditing during due diligence investigations, to federal and state licensure requirements, and the development and implementation of improved compliance programs post-closing. She now brings this experience in navigating the FDA landscape to Medmarc, where she works with colleagues in house, as well as with policy holders, in developing regulatory compliance strategies in an effort to mitigate products liability losses.
Ms. Klaus is a graduate of The Catholic University of America, Columbus School of Law, and the College of the Holy Cross. She is a member of the Massachusetts Bar.