DEBORAH L. LIVORNESE is Director at Hyman, Phelps & McNamara, PC in Washington, DC. Ms. Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements. 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 or purchasers. Prior to joining Hyman, Phelps & McNamara, Ms. Livornese spent seven years in the Office of Regulatory Policy in FDA’s Center for Drug Evaluation and Research. 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, and opioid drugs, and user fee programs. Prior to joining FDA, Ms. Livornese 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.