FDA Regulatory

DLA Piper’s FDA Regulatory practice has extensive experience in all areas of FDA regulation including pharmaceuticals, biological products, medical devices, clinical laboratories, in vitro diagnostics, combination products, food and beverages, dietary supplements, cosmetics, cannabis, veterinary drugs, and animal feed. We provide comprehensive regulatory services across your product life cycle. From routine counseling matters and marketing authorizations for your most strategic regulated products, to bet-the-company crises, we understand both your products and business goals, and provide practical, nuanced counsel and effective advocacy across all regulatory or judicial arenas.

Beyond establishing and maintaining compliance with existing laws and regulations, we help you anticipate, adapt, and where possible, benefit from changes in the legal, regulatory, public policy and legislative landscapes.

With a team that includes former industry executives, in-house counsel, officials at the FDA and other government agencies, physicians, scientists, legislators, and legislative staff, we view your challenges and opportunities through different lenses, providing a distinct advantage in perspective, analysis, and judgment. When multi-jurisdictional advice is needed, we work closely with our colleagues around the world to provide seamless solutions with the benefit of local perspective. Our global reach coupled with our team’s unique perspective set us apart.

Well integrated into our firm’s sector groups, our team has a broad view of the commercial and regulatory forces affecting clients in the health care, consumer products, food and beverage and life science industries. Our approach is multidisciplinary, and we routinely collaborate with public policy, intellectual property, healthcare regulation, corporate transactions, litigation and other DLA Piper lawyers to provide seamless solutions with strong results.

We leverage the full scope of the DLA Piper platform, combining practice, sector and geographic strength to provide bespoke counsel to help you achieve your goals.

We provide the full range of support services for companies engaged in FDA-regulated activities including deal diligence, advising and drafting of all manner of related contracts, and counseling related to public disclosure and reporting. We also provide counseling and representation in diverse areas that include product development and testing, marketing authorizations, regulatory exclusivities, government inspections, third-party audits, product and ingredient notifications, recalls, corrective actions, diligence projects and audits, advertising and marketing, and GXP compliance.

Our team also works with other product-regulating governmental agencies including the Department of Agriculture (USDA), Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), Alcohol and Tobacco Tax and Trade Bureau (TTB), National Institutes of Health (NIH), and Drug and Enforcement Agency (DEA), as well as standards organizations such as the National Institute for Occupational Safety and Health (NIOSH) and compendia such as the United States Pharmacopeia (USP). We also routinely advise on state regulation of product distribution as well as regulation of testing products and facilities under the Clinical Laboratory Improvement Amendments (CLIA).

If your business is in an FDA-regulated industry, we are a full-service FDA Regulatory Practice that offers specialized regulatory experience and perspective, and we are able to draw at once on an immense pool of talent and resources across multiple disciplines and geography, that we tailor to fit each of our client’s needs to achieve their goals.

• Advised a global medical device company regarding its diabetes business across 29 jurisdictions, on whether it can market, sell, and ship products directly to customers.
• Counseled a US medical technology company on all aspects of medical device regulation including discontinuing a previous version of their medical device in 40 countries, rolling out a sampling program with HCPs throughout Europe, and transparency obligations in the MedTech and national industry codes.
• Assisted a US pharmaceutical company in reviewing their internal compliance policies related to medicinal product promotion and HCP interactions in 31 jurisdictions worldwide.
• Participated in a major pharmaceutical company’s promotional review committee as regulatory counsel with responsibility for prescription anti-infective, cardiovascular, pain, and women's health drug products.
• Represented a global biopharmaceutical company on EU cell and gene therapy regulation, including compliance with the EU Tissue and Cells Directive, ATMP Regulation, and other regulatory challenges.
• Provided successful regulatory strategy for a third-party-initiated OTC switch of a blockbuster prescription drug.
• Advised a global medical device company regarding its diabetes business across 29 jurisdictions, on whether it can market, sell, and ship products directly to customers.
• Counseled a US medical technology company on all aspects of medical device regulation including discontinuing a previous version of their medical device in 40 countries, rolling out a sampling program with HCPs throughout Europe, and transparency obligations in the MedTech and national industry codes.
• Assisted a US pharmaceutical company in reviewing their internal compliance policies related to medicinal product promotion and HCP interactions in 31 jurisdictions worldwide.
• Participated in a major pharmaceutical company’s promotional review committee as regulatory counsel with responsibility for prescription anti-infective, cardiovascular, pain, and women's health drug products.
• Represented a global biopharmaceutical company on EU cell and gene therapy regulation, including compliance with the EU Tissue and Cells Directive, ATMP Regulation, and other regulatory challenges.
• Provided successful regulatory strategy for a third-party-initiated OTC switch of a blockbuster prescription drug.
• Represented a global pharmaceutical organization on its negotiations for the supply of its COVID-19 vaccine across EU and EEA countries.
• Counseled a US CRO on the implementation of clinical trial-related services following the acquisition of another entity in more than 50 jurisdictions worldwide.
• Advised a private equity client on FDA compliance issues faced by an acquisition target medical device company, including corrective action plans post-acquisition.
• Drafted a Supreme Court amicus brief in a case striking down state law restrictions on the use of physician prescribing data by pharmaceutical companies for marketing purposes on behalf of two leading orphan drug patient advocacy groups.
• Served as regulatory counsel in a successful US Supreme Court case broadening the scope of the FDA research exemption to patent infringement under the Hatch-Waxman Amendments on behalf of a research-based pharmaceutical company (Merck KGaA v. Integra Life Sciences).