Food, Drug and Medical Device

Clients seek our advice on all aspects of the development, manufacture, and marketing of products regulated by FDA and other agencies:

• An elite cross-border regulatory practice: Our lawyers have advised on the most challenging legal issues, including real-world evidence, compounding, combination products, accelerated approval and related pathways, and data and privacy issues. We provide comprehensive strategic support for innovation across the entire regulatory spectrum, including product development, marketing authorization, pharmacovigilance, strategic planning for market access, post marketing compliance, and lifecycle management. We also handle a broad range of contentious and non-contentious proceedings on behalf of clients challenging unfavorable decisions by regulatory authorities. This includes matters arising out of FDA premarket review processes (such as refusal to file, complete response letter, and supervisory appeal issues), post-marketing developments, and complex policy questions presented in rulemaking and other policy contexts.
• Compliance-focused, technically oriented approach to risk management and investigation support: Sidley’s premier compliance and enforcement team, the largest of any law firm, counsels clients in more than 20 countries and across industries on current Good Manufacturing Practice (cGMP)/Quality System Regulation (QSR), Good Clinical Practice (GCP), and adverse event reporting matters. We provide training on best practices and inspection readiness while developing strategies for responses to agency actions, including FDA Form 483s, warning letters, and consent decrees; we bring a high level of technical knowledge and understand the expectations of regulators. Our lawyers also are well-versed in assessing compliance risks, conducting internal compliance investigations, and in representing clients in False Claims Act litigation.
• Leaders in novel products: Our Food, Drug and Medical Device team counsels a diverse range of clients — from Fortune 10 pharmaceutical companies and multinational, innovator medical device and biotechnology manufacturers, to startups and development-stage companies. We offer deep experience on the regulatory, compliance, and enforcement issues involving innovative and novel products, including vaccines, digital health technologies, regenerative medicines, gene and cell therapies, OTC drugs, APIs, dietary supplements, antibiotics, cell-based protein alternatives, and clinical diagnostic devices. We help clients to navigate important orphan drug and exclusivity issues.
• Deep bench of FDA experience: Sidley’s Food, Drug and Medical Device team is bolstered by the practical knowledge and senior-level government experience of our team. This includes a deep bench of veterans from the U.S. Food and Drug Administration Office of Chief Counsel, including former Chief Counsel and Acting Chief Counsel, former FDA inspectors, and former policy advisors and reviewers within the agency. In addition, our team includes alumni of The White House Counsel’s office, U.S. Department of Justice, Department of Health & Human Services, Centers for Medicare & Medicaid Services, European Commission, and Swissmedic.
• Scientific and technical perspective: Our team also includes a physician, a veterinary surgeon, lawyers with advanced technical degrees, and a former quality control microbiologist.
• Government agency insight: Our lawyers have represented numerous clients before the FDA, European Medicines Agency, European Commission, National Medicinal Products Administration (China), Medicines and Healthcare Products Regulatory Agency (MHRA), the Swiss Agency for Therapeutic Products (Swissmedic), and other related government authorities. Leveraging our technical experience and strategic insight, we have advocated successfully on behalf of our clients in investigations and enforcement and regulatory proceedings around the world.