Tiffany Humphries

Tiffany M. Humphries

Associate
Baker & McKenzie LLP

Biography

Tiffany M. Humphries is an Associate in the North America Food and Drug Administration Practice Group for Baker McKenzie. Tiffany focuses her practice on assisting clients with regulatory, compliance and enforcement matters for US Food and Drug Administration (FDA)-regulated products, including food, cosmetics, drugs and medical devices. She leverages her deep understanding of the Federal Food Drug & Cosmetic Act (FD&C Act) to represent clients in research, pre-launch, launch, commercialization and licensing activities for first-in-class products and other innovative products.

Prior to joining Baker McKenzie, Tiffany worked as an Associate Chief Counsel at the U.S. Food and Drug Administration, Office of the Chief Counsel. While there, she gained over 6 years of experience on the foods, cosmetics, and drugs teams. In this role, she advised FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Drug Evaluation and Research (CDER) on policy initiatives, guidance documents, proposed and final rules, administrative actions, enforcement actions, rule implementation, audit responses, and technical assistance for Congress. Prior to FDA, Tiffany spent 2 years at a large firm, specializing in FDA and Federal Trade Commission (FTC) law.

Practice Focus

Tiffany focuses her practice on assisting clients with regulatory, compliance and enforcement matters for FDA-regulated products, including food, cosmetics, drugs and medical devices. She represents clients in research, pre-launch, launch, commercialization and licensing activities for first-in-class products and other innovative products. Clients also seek Tiffany's counsel on developing innovative strategies for FDA approval and compliance with FD&C Act and Public Health Service Act regulatory requirements for investigational and marketed products including current good manufacturing practices (cGMPs), promotion and marketing, interstate conveyance sanitation, supply chain and quality issues. Moreover, Tiffany advises clients on strategies for addressing critical regulatory matters, including inspection observations, untitled letters, warning letters, voluntary and mandatory recalls, dispute resolution issues and advisory committee comments. Tiffany also advises cosmetics, food and dietary supplement clients on FDA and Federal Trade Commission (FTC) regulated labeling, advertising and promotion matters.

Further, in Tiffany's practice, she works with large, mid-size and emerging life sciences clients on a variety of transactional issues including acquisitions, divestitures, collaborations, clinical trials and related agreements.

Professional Honors

  • American University, Key Executive Leadership Program, November 2017 - May 2018
  • Commissioner’s Award of Excellence, 29 June 2017

Admissions

  • District of Columbia~United States

Education

  • Vanderbilt University Law School (JD) (2012)
  • University of Pennsylvania (BA cum laude) (2008)

Languages

  • English