Like the agency itself, we have dedicated, interdisciplinary practices focusing on each segment of the Food and Drug Administration (FDA) and the Federal Food, Drug and Cosmetic Act (FDCA). We partner with stakeholders in the food, pharmaceutical, health and life sciences, and other affected industries to navigate FDA regulations and agency interactions. From new medical devices and biotechnology to innovative food products and cosmetics, companies, patient organizations and other stakeholders rely on us to provide experienced advice to navigate the FDA.

Drugs and Medical Devices

As a drug and medical device innovator, patient organization, or other stakeholder in the drug or device approval process, your success relies on your ability to comply with a complex framework of regulations related to research and development, marketing authorization and post-marketing compliance. We support you throughout this process, walking with you from the early research stages, to the clinic, to Agency submission and approval and on to post-market safety monitoring. Our experienced team leverages an interdisciplinary bench of lawyers, consultants and scientists to provide you with insight and practical advice. We handle matters including clinical trial contracting, research compliance, product development strategy and agency relations, patient focused drug development (including patient advocacy group collaborations), good manufacturing practices, laboratory audits,  Agency determinations (i.e., INDs, IDEs, and expanded access), advertising, promotion, privacy enforcement and related matters. We also support clients as they innovate using cutting-edge digital, Artificial Intelligence (AI), machine-learning (ML), and other software-based technologies.  

Food and Dietary Supplements

Leading food and dietary supplement companies confront critical legal, regulatory and business challenges every day. We help you develop and execute strategies related to the science, economics, markets, government regulation and public relations aspects of the farm to-table cycle. When disputes, regulatory changes or product recalls emerge, our regulatory and litigation teams provide peace of mind as you implement new compliance protocols or tackle high-stakes litigation.


Makers of cosmetics and personal care products must continuously adapt and expand product offers to reflect the growing desire of consumers to express their beauty and individuality. Creative marketing and advertising of these products may exceed lawful conduct and result in enforcement action by regulatory agencies. States have become increasingly involved in cosmetic regulation as it relates to product ingredients and consumer health. We work with you to meet these emerging challenges head-on. We review product ingredients and advise on prospective advertising and labeling claims that are the basis for legal challenges by regulators and competitors.

Animal Health

Companies making new animal drugs, biologics, pet food, feed additives and animal feed need in-depth knowledge to identify and implement efficient development, manufacturing and marketing of animal food and drugs. We guide clients through interactions with the FDA and the United States Department of Agriculture by delivering industry insight and practical advice on complex legal issues related to adverse event reporting, recalls, criminal investigations and product liability.

Insights & Events

Speaking Engagement June 07, 2023

Federal Legislative Opportunities for Improved Cannabis Regulation - Webinar

FDLI’s Legal and Practical Issues in Cannabis Regulation Conference
Jun 07, 2023  
Updates May 2023

Supreme Court Decides National Pork Producers, et al. v. Ross et al.

4 min read  
Published Articles March 2023

Something Tastes Different: Is Medication Flavoring Compounding?

1 min read  
Speaking Engagement Recap March 24, 2023

Heavy Metals, PFAS, and Other Contaminants: Making Sense of the State and Federal Regulatory Landscape

FDLI’s 2023 Food and Dietary Supplement Safety and Regulation Conference
1 min read  
Published Articles February 2023

As States Begin to Legalize ‘Magic’ Mushroom Use, Boards of Pharmacy and Pharmacists Should Stay Alert and Informed

2 min read  
Press Release February 2023

Faegre Drinker Elevates 6 Consulting Professionals to Principal

3 min read  
Speaking Engagement Recap December 06, 2022

Assessing the Impact of the Recent Supreme Court Session on the Drug and Medical Device Industry and Upcoming Preemption Battles

ACI’s 2022 Drug & Medical Device Litigation Conference
1 min read  
Updates September 2022

Biden Administration Announces New Competition Enforcement Efforts in Agriculture

6 min read  
Published Articles September 2022

FDA Proposes National Licensure Standards for Wholesale Drug Distributors and Third-Party Logistics Providers

1 min read  
Press Release October 2021

Pharmaceutical Industry Advisor Dr. Joe Lamendola Joins Faegre Drinker Consulting as Senior Director

2 min read  

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