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Overview

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. Companies, patient organizations and other stakeholders rely on us to provide experienced advice to help them meet regulatory expectations and navigate the FDA when they’re working with new drugs, biologics, and medical devices and related biotechnology or innovative food products and cosmetics.

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 the life cycle of a medical product — from the early research stages to the clinic, to Agency submission and approval, and on to post-marketing commitments and ongoing safety monitoring. 

Our experienced team includes attorneys with extensive experience.  Team members have worked on issues before the FDA’s Center for Drug Evaluation and Research including drug and biologics policy matters before the Office of Pharmaceutical Quality and compliance matters (including 483 responses and warning letters) before the Office of Compliance. The team leverages an interdisciplinary bench of attorneys, consultants and scientists to provide you with insight and practical advice. We handle matters including:

  • Clinical trial contracting
  • Research compliance
  • Product development strategy and early agency interactions
  • Patient-focused drug development (including patient advocacy group collaborations)
  • Software as a medical device
  • Current good manufacturing practice (CGMP) and quality system regulations and expectations
  • Laboratory audits
  • Agency determinations (i.e., INDs, IDEs and expanded access)
  • Risk evaluations and mitigation strategies (REMS)
  • Promotional communications and advertising
  • Privacy protection policies and enforcement
  • Post-marketing surveillance

We also support clients as they innovate using advanced manufacturing techniques and platform technologies, 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, product recalls or legal suits emerge, our regulatory and litigation teams provide peace of mind as you implement new compliance protocols or tackle high-stakes litigation.

Cosmetics

Makers of cosmetics and personal care products must continuously adapt and expand product offerings to reflect the growing desire of consumers to express their beauty and individuality. At the same time, oversight has never been greater, as we watch FDA implement federal legislation to modernize cosmetics regulation. Creative marketing and advertising of these products may fall outside legal parameters 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, help navigate registration requirements 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, medicated feeds and feed additives as well as pet food and animal feed need in-depth knowledge to identify applicable regulations 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

Latest

Insights
Updates May 2025

Is This the Death Knell of Strict Liability Crimes?

The Impact of President Trump’s May 9, 2025, Executive Order on Regulatory Criminal Offenses & FDCA Enforcement
10 min read  
Media Mentions May 2025

Barrett Tenbarge Provides Insights on FDA Staffing Cuts for Chemical & Engineering News

1 min read  
Updates May 2025

HHS and FDA Launch RFI on Deregulatory Plan — A Key Opportunity to Shape Health and Food Policy

Submissions Through Regulations.gov Due July 14, 2025
4 min read  
Updates May 2025

FDA Identifies Data Quality and Study Conduct Concerns With Raptim Research and Requires Sponsors to Submit Replacement Study Data

Reminder of Importance of Adequately Vetting Contract Research Organizations
5 min read  
May 2025

The Hidden Dangers of Alternative Funding Programs

1 min read  
Updates April 2025

The Effects of HHS Workforce Reductions, Tariffs on Pharma, the ‘Pill Penalty’ and More

Biopharma & Medical Devices Briefing
5 min read  
Updates April 2025

Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act

CMS Regulates Laboratory-Developed Test Services Under the Clinical Laboratory Improvements Amendments (CLIA) of 1988
12 min read  
Published Articles April 2025

Accuracy of Medicare Information Provided by State Health Insurance Assistance Programs

1 min read  
Published Articles March 2025

Breaking the Silence: Challenges and Opportunities in Pediatric Drug Development

1 min read  
Updates March 2025

HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

After the Department’s Recission of the Richardson Waiver, Drug and Device Industry Loses Powerful Check Against FDA Overreach
6 min read  

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