FDA Regulatory & Compliance Law

Overview

The U.S. Food and Drug Administration (FDA) regulates a broad range of products central to the U.S. economy, including human and animal drugs, medical devices, and food products, as well as biological products, dietary supplements, cosmetics, and tobacco products. We represent companies across these industries, providing strategic regulatory counsel tailored to the unique requirements associated with each product. Our practice is not limited by geography; we represent clients in the Southeast, nationwide, and internationally, including foreign companies seeking to introduce FDA-regulated products into the U.S. market or to open domestic manufacturing facilities.

We advise clients at every stage of the product lifecycle — from development and pre-market authorization through manufacturing, labeling, marketing, distribution, and post-market compliance. Because FDA compliance directly affects core business operations, regulatory missteps can halt product launches, disrupt supply chains, trigger inspections or enforcement actions, and create significant legal and reputational risks. Clients rely on us to navigate regulatory risk — not only to respond when issues arise but to anticipate regulatory expectations and build compliance strategies that reduce exposure before problems occur.

Our group is led by Marci Norton, who spent nearly 30 years in the FDA's Office of the Chief Counsel (OCC). We are uniquely positioned to help clients understand how the agency evaluates compliance and pursues enforcement. We combine deep regulatory knowledge with practical, business-focused guidance to help clients meet public health and safety obligations while protecting their operational and commercial objectives.

Areas of Focus

Regulatory Counseling

Advise clients across the full range of products regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (FDCA) and parts of the Public Health Service Act, including both human and animal drugs, medical devices, and food products, as well as biological products, dietary supplements, cosmetics, and tobacco products.

Lifecycle & Market Entry Support

Guide companies from early development and approval strategy through manufacturing, processing, labeling, marketing, distribution, and post-market safety and compliance obligations.

Enforcement & Investigations

Represent clients in FDA inspections, responses to Form 483 observations and correspondence from FDA (e.g., warning and untitled letters, notices of noncompliance), administrative enforcement actions, and judicial criminal and civil litigation. Drawing on direct agency experience, we guide clients through high-stakes regulatory scrutiny and defense.

Compliance & Risk Mitigation

Help clients anticipate and address regulatory requirements before issues escalate into violative inspections, product delays, recalls, or enforcement proceedings.

Regulatory Issues in Litigation & Transactions

Advise when FDA compliance intersects with commercial litigation, patent litigation brought under the Drug Price Competition and Patent Term Restoration Act (the “Hatch-Waxman Act”), government investigations, corporate transactions, and licensing arrangements involving regulated products.

Strategic Engagement With the Agency

Provide insight into how regulatory decisions are made and how the agency operates in practice, enabling clients to engage effectively and efficiently with FDA and other regulatory agencies.

Representative Experience

Advising a life sciences company that manufactures allergy immunotherapy products through an unexpected FDA inspection; raising compliance concerns; providing real-time counseling on responding to investigators; managing agency interactions; and mitigating enforcement risk before escalation.
Representing a client in complex federal litigation where FDA regulatory issues are central to trademark and commercial claims involving prescription drug importation.
Representing and counseling numerous generic pharmaceutical companies on nearly 200 drug molecules, across more than 20 different therapeutic areas, regarding the preparation and filing of Abbreviated New Drug Applications (ANDAs) and 505(b)(2) New Drug Applications (NDAs) with the FDA and in related patent litigation brought under the Hatch-Waxman Act.
Represented a generic pharmaceutical company in multiple ANDA cases in federal district courts in Delaware, New York, New Jersey, West Virginia, and South Carolina; negotiated settlement terms cutting off the exclusivity period of the holder of a NDA.
Prevailed before the Federal Circuit on motion for judgment on the pleadings demonstrating that our client’s generic pharmaceutical drug did not infringe on the sole remaining asserted patent covering a branded product with annual U.S. sales exceeding $3 billion. The case involved a successful defense of our client’s 505(b)(2) application.
Advising startups and entrepreneurs exploring novel or unconventional FDA regulated products; helping them assess feasibility, understand regulatory pathways, and evaluate risk before committing significant capital.
Negotiating and litigating numerous FDA, Federal Trade Commission (FTC), and Consumer Product Safety Commission (CPSC) proceedings, involving off-label marketing of drugs and medical devices, tobacco fraud and regulation, FDA approval and clinical testing, compounding pharmacies, as well as current good manufacturing practice (CGMP) and food and drug inspection issues.
Representing a chain of vape stores in an enforcement action by the FDA and U.S. Department of Justice (DOJ) for violating laws on marketing unauthorized tobacco products.
Represented the quality assurance manager of a dietary supplement manufacturer in grand jury and FDA investigations regarding the sale of contaminated batches of products, resulting in no charges being brought against the client.
Preserved the license of a compounding pharmacy and ensured it remained operational when confronted with industry and government allegations that it was producing an alternative version of an FDA-approved drug outside the parameters of the FDCA §§ 503A and 503B.
Represented diagnostic laboratories before the FDA, Congress, and the Centers for Medicare & Medicaid Services (CMS) on regulatory and legislative issues.