Katlin McKelvie Backfield

Counsel
T: (617)-274-2864
  • Georgetown University (J.D., 2001), cum laude
  • Davidson College (A.B., 1996), cum laude

Biography

With more than 15 years of pharmaceutical and biotechnology regulatory experience, including more than 10 years at the Food and Drug Administration, Katlin helps companies navigate the pre- and post-approval stages of pharmaceutical and biotechnology product development.

Katlin advises on a wide range of issues related to the regulation of drugs and biologics. Her practice focuses primarily on advertising and promotion; manufacturing and inspections; importation; postmarketing safety requirements, including the development and implementation of Risk Evaluation and Mitigation Strategies; approval pathways; user fees; labeling development; medical countermeasures; and information disclosure.

While at FDA, Katlin was an Associate Chief Counsel for Drugs in the Office of Chief Counsel, where she advised Agency officials on complex and novel issues touching on almost every area of drugs law. She also served as a regulatory counsel in the Division of Drug Marketing, Advertising, and Communications (DDMAC) (now the Office of Prescription Drug Promotion) in the Center for Drug Evaluation and Research. Prior to joining FDA, Katlin was an associate at Hogan & Hartson LLP (now Hogan Lovells LLP).

Katlin lives in Washington, D.C., with her husband and two children. In her free time, she enjoys picking up toys, matching up stray socks, and performing stand-up comedy.

Education

  • Georgetown University (J.D., 2001), cum laude
  • Davidson College (A.B., 1996), cum laude

Clerkships

  • Hon. Douglas P. Woodlock, U.S. District Court for the District of Massachusetts

Bar Admissions

  • Washington, D.C., 2002