Steven J. Gonzalez Associate 202-800-3511
Steven J. Gonzalez
Practice Areas
Industries
FDA Regulatory Categories

Overview

Steven focuses his practice on FDA regulatory matters and advises life sciences and health care clients on a broad range of pre- and post-market regulatory and compliance issues under the Food, Drug and Cosmetics Act and related laws, including product development and marketing approval, advertising and promotion, and inspection and enforcement matters. Steven also routinely provides regulatory counsel for corporate transactions, license and collaboration agreements, manufacturing and supply arrangements, and public and private securities offerings involving drug, device, cosmetic, food, and dietary supplement companies.

Prior to joining Hyman Phelps & McNamara, Steven was an associate in the FDA regulatory department of a large international law firm in Washington D.C. While in law school, Steven assisted pro bono clients as part of the Harvard Food Law and Policy Clinic and was the President of the Harvard Food Law Society.

Education & Admissions

Education

  • J.D., Harvard Law School, 2017; Executive Editor, Harvard Law and Policy Review
  • B.A., University of California, Santa Barbara, 2012, Cum Laude

Experience

  • Regularly performed FDA due diligence for IPOs and follow-on offerings of early and late-stage pharmaceutical and biotech companies and other acquisitions and investments in FDA-regulated firms on behalf of both private equity and strategic buyers.
  • Reviewed and revised orthopedic 510(k) submissions for a major medical device manufacturer.
  • Counseled companies regarding informed consent, IBR approval, and IDE requirements for clinical research.
  • Provided regulatory counsel, transactional support, and promotional review for a biotechnology company that provides COVID-19 diagnostic testing to a broad range of organizations, including airports, schools, and businesses.
  • Managed drafting, submission and interactive FDA review of pre-EUA and EUA requests for a respiratory device, COVID-19 diagnostic and serology tests, and ventilator accessories, including advice on clinical study protocols.
  • Evaluated intended use and algorithm of clinical decision support software to determine its FDA regulatory status.
  • Drafted commercial regulatory contracts, including supply, distribution, laboratory services, and quality agreements.
Education
  • J.D., Harvard Law School, 2017; Executive Editor, Harvard Law and Policy Review
  • B.A., University of California, Santa Barbara, 2012, Cum Laude
Practice Areas
Industries
FDA Regulatory Categories