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Education

  • J.D., University of Maryland Francis King Carey School of Law, with honors
  • B.S., University of Maryland,
    summa cum laude

Bar Admissions

  • District of Columbia
  • Maryland

Memberships & Affiliations

American Bar Association

Co-Chair, ABA Life Sciences Division

Co-Chair, ABA Biotechnology Law Committee

Vice-Chair, Programming Committee, ABA Science and Technology Section

Bloomberg Law Advisory Board

Member, 2019 Food and Drug Law Institute

Women in Bio

Federal Bar Association

Deborah M. Shelton

  • |
Practice Group Leader
  • T: 202.753.3354
    F: 202.354.4633

Deborah M. Shelton is Leader of the Food & Drug Law Practice at McCarter & English, LLP.
 
Deborah provides clients with deep industry-relevant experience in drugs, biologics, medical devices, foods, cosmetics, and dietary supplements. Her practice is informed by a strategic, rigorous, and pragmatic approach to client counseling gained from 20 years of serving in diverse settings, including in key external and corporate counsel roles.

Deborah represents clients across numerous federal regulatory agencies, including the FDA, USDA, DEA, and the FTC. Deborah has also represented clients in matters before state and federal legislative bodies. She represents companies of all sizes, from start-up enterprises to multinational corporations, on navigating complex regulations that affect business planning, product development and approval, labeling, advertising and promotion, due diligence and contracting, and legislative and regulatory advocacy.

Deborah also enjoys working closely with colleagues in other practice areas to provide clients with 360 degree advice on issues of significant interest to them. For example, Deborah frequently serves as the regulatory subject matter thought leader in litigation involving FDA-regulated companies; leveraging her extensive experience with Hatch-Waxman and regulatory exclusivities, Deborah works closely with her IP colleagues on issues at the intersection of patent and regulatory; and Deborah partners with her corporate colleagues to provide FDA regulatory advice on due diligence and other transactional matters.

Keeping pace with the ever-evolving legal landscape, Deborah also analyzes federal laws, regulations, and legislative proposals relevant to the burgeoning cannabis industry. She provides strategic counseling and regulatory advice to companies seeking to enter the cannabis market and assists clients with responding to shifting legal and public policy issues at the federal level.

Deborah is passionate about working with a diverse group of stakeholders, including patients, industry, FDA and NCI, to raise awareness of the critical need for, and interest in, advancing therapies for rare cancers and patient-focused drug development across all diseases.

Deborah has been an industry leader in the development of the legislative biosimilar pathway and FDA’s implementation. Prior to returning to private practice at McCarter & English, she served as Deputy General Counsel for Healthcare at BIO, the world’s largest biotech trade association. She joined BIO from the Washington, D.C. office of a global biotechnology company, where she was lead U.S. counsel to the company’s Global Regulatory Policy and Government Affairs teams. Prior to her work as corporate counsel, Deborah was a partner in the FDA practice of a Global 100 firm.

Deborah has taught numerous courses, including for the Food & Drug Law Institute (FDLI), and is very active in the American Bar Association (ABA). She was co-editor of the FDCA Statutory Supplement (2018), and has published and spoken extensively on a wide array of issues of interest to FDA-regulated industries.

Speaking

05/02/19
10/03/18
Introduction to Biologics and Biosimilars Law and Regulation - Food and Drug Law Institute
03/09/18
American Conference Institute’s FDA Boot Camp
10/03/17
Paragraph IV Disputes Master Symposium - Chicago, IL; American Conference Institute