Alexandra S. Marzelli is counsel in the firm’s Health Care Group and a member of the FDA Team.
As an associate chief counsel at the FDA, Alix focused on generic and 505(b)(2) drug, biosimilar biological, and combination product issues. She advised on advertising and promotion matters, counseled on user fee appeals, and provided technical assistance to Congress on legislation. She received a Certificate for Distinguished Service from the U.S. Department of Health & Human Services for her work as part of the Office of the Chief Counsel’s COVID-19 response team. The U.S. Public Health Service recognized Alexandra with a certificate of appreciation for outstanding individual contributions and selfless support of the responses to Hurricanes Harvey and Irma.
As senior regulatory counsel, Alix advised Becton, Dickinson and Company on medical device and diagnostic regulatory and quality matters, including promotional claim substantiation, quality agreements, and internal investigations. Additionally, she advised on product quality risk management and promotional review policies and on the regulation of mobile medical health devices, clinical decision support software, and laboratory-developed tests.
Alix was previously in private practice with two Washington, D.C. law firms, where she provided strategic advice on litigation and FDA regulatory matters.