Deborah L. Livornese Of Counsel 202-737-9638
Deborah L. Livornese

Overview

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.

Education & Admissions

Education

J.D., cum laude,  University of California, Hastings College of the Law
B.A., Biological Basis of Behavior, University of Pennsylvania

Admissions

District of Columbia
California

Honors & Awards

  • JD Supra Readers’ Choice Top Author Award, 2018
  • Member of the Editorial Advisory Board – Journal of Food and Drug Law,  2008-2012
  • Member of Activities Committee, FDA Alumni Association,  2017-Present

Speaking Engagements

  • FDLI’s Introduction to US Drug Law and Regulation, Regulation of Over-the-Counter (OTC) Drugs, November 2018
  • FDLI’s Introduction to Drug Law and Regulation for CDER/ORISE Fellows, OTC Drugs, October 2018
  • FDLI’s Introduction to US Drug Law and Regulation, Regulation of Over-the-Counter (OTC) Drugs, April 2018
  • FDLI Annual Meeting, OTC Monograph Reform, May 2018
Education

J.D., cum laude,  University of California, Hastings College of the Law
B.A., Biological Basis of Behavior, University of Pennsylvania

Admissions

District of Columbia
California

Practice Areas
Industries
FDA Regulatory Categories