Deborah’s practice covers a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on drug development and regulatory strategies related to obtaining FDA approval, as well as on post-marketing regulatory requirements, including drug promotion and advertising. Ms. Livornese also assists clients in connection with commercial transactions and public offerings by conducting FDA regulatory due diligence on behalf of regulated companies and potential investors and purchasers.
Deborah spent seven years in the Office of Regulatory Policy in FDA’s Center for Drug Evaluation and Research prior to joining HPM in 2018. As a Senior Regulatory Counsel at FDA, she was involved in a wide variety of policy issues in the areas of drug approvals and withdrawals, the regulation of unapproved and over-the-counter drugs, opioid drugs, and user fee programs.
Prior to joining FDA, Deborah was Of Counsel with an FDA boutique law firm in Washington DC where she advised drug companies on promotional activities for compliance with FDA, FTC and HHS requirements, and assisted clients in responding to investigational findings, warning letters, and inquiries from the FDA and other agencies. Her full bio can be found here.
Serra joined HPM in July 2016. Prior to joining the firm, Serra was an associate in the health care and life sciences practice of a national law firm. Before beginning her legal career, Serra worked in clinical administration at Memorial Sloan-Kettering Cancer Center, gaining practical experience that she continues to draw upon when counseling clients.
Serra’s broad practice covers the intersection of health care and FDA law. She works with clients across all of HPM’s practices areas. Serra assists clients with a wide range of regulatory matters including developing regulatory strategy, drafting compliance policies and procedures, reviewing advertising and promotional materials, and evaluating and updating data privacy and patient health information policies and practices (HIPAA). Serra has specific expertise with regard to federal and state health care fraud and abuse laws and defends clients in connection with government investigations and other enforcement inquiries. She advises clients on the many legal and regulatory issues associated with telemedicine, laboratory developed tests (LDTs), and CLIA certification. She also helps clients with contract matters and regulatory due diligence. Serra was shortlisted for the 2019 LMG Life Sciences “US Rising Star – Regulatory” award. Her full bio can be found here.