Entities regulated by the Food and Drug Administration (FDA)—including manufacturers, wholesalers, distributors, 3PLs, and retailers—and their investors require the legal insight and business acumen of an FDA Regulatory and Compliance practice with a breadth of experience across the development, manufacturing, distribution, and marketing of FDA-regulated products. That is the Sidley FDA Practice—we partner with our life sciences and medtech clients to provide practical, business, and risk-focused strategic advice on bread-and-butter issues as well as the novel, cutting edge, and bet-the-company issues that arise in a scientifically and technologically changing world.
Our team includes lawyers and compliance advisors with experience in senior roles at FDA, the Department of Health and Human Services, and other federal agencies and legislative bodies, as well as with advanced technical degrees. Our practice is experienced and wide-ranging, and we have deep knowledge across the areas FDA regulates including pharmaceuticals, biologics, vaccines, gene and cell therapies, devices, combination products, diagnostics, digital health, AI, software, animal health, OTC drugs, foods, infant formula, dietary supplements, and cosmetics.
Sidley’s FDA practice is nationally recognized for its excellence and consistently earns top-tier rankings in leading legal directories, including Chambers USA, LMG Life Sciences, and U.S. News – Best Lawyers. The team has repeatedly been honored as a standout in the field, receiving the “Law Firm of the Year” award in FDA Law from U.S. News – Best Lawyers in 2020, 2022, and 2024.
Our areas of focus include:
- Evaluation of Premarket Regulatory Strategies: We help clients navigate the best pathways to get their FDA-regulated products to market, in light of product classification considerations and development and clinical trial issues. We guide our clients through important agency interactions (e.g., FDA and Advisory Committee meetings) and help ensure that communications with the agency are strategically aligned.
- Market Exclusivities: We regularly advise on Hatch-Waxman market exclusivity, as well as obtaining and protecting orphan drug and pediatric market exclusivity.
- Labeling, Advertising, and Promotion: We counsel clients on labeling, advertising, and promotion issues, considering FDA, FTC, and NAD requirements and precedent. We address marketing practices for our clients—conducting comprehensive label reviews, assessing claims and claim substantiation, counseling on “off-label” communications, as well as the complexities and nuances of internet and social media promotion. We track FDA Warning Letters, Courtesy Letters, False Claims Act matters, and other enforcement actions to keep our fingers on the pulse of areas of heightened scrutiny and risk.
- Compliance and Enforcement: We advise companies on all aspects of “GxP” compliance—including Good Manufacturing Practice (GMP) and the Quality System Regulation (QSR), Good Clinical Practice (GCP), Good Laboratory Practice (GCP), and Good Pharmacovigilance Practice (GVP)—as well as data integrity, supply chain/distribution, and safety/pharmacovigilance issues. Our team conducts internal investigations and risk assessments, guides clients in implementing enterprise-wide compliance programs and develops strategic responses to 483s, Warning Letters, and Untitled Letters. We help clients prepare for inspections, provide support during inspections, and assist in arranging and preparing for Regulatory Meetings with FDA, with additional support from our technical experts, who include former FDA inspectors.
- Advocacy and Contentious Proceedings: Unique among law firms, Sidley’s FDA team handles a broad range of contentious and non-contentious proceedings involving FDA, advocating on behalf of clients to resolve disputes with the agency. This work ranges from agency legal and regulatory meetings to Citizen Petitions, Advisory Committee meetings, informal and formal agency appeals and dispute resolution, and hearings. We address complex and often unprecedented legal, regulatory, public health, and policy questions presented in clinical holds, refusals to file (RTF), complete response letters (CRL), approval and withdrawal determinations, rulemaking, guidance documents, and other contexts. Where it becomes necessary, our work extends to judicial review of agency proceedings and related litigation.
- Life Science Transactions: We partner with our Life Science colleagues on the full range of corporate transactions, preparing companies for transaction-related scrutiny, conducting diligence, structuring sound contingent value rights (CVR) and milestone provisions, and helping with post-transaction integration activities. We assess product classification, marketing pathway, supply chain, regulatory exclusivity, compliance history, enforcement potential, and numerous other issues that may impact transaction value. We also apply our experience and deep understanding of the risks and opportunities facing all Life Science companies in an evolving regulatory environment, not only to help evaluate regulatory risk but also to help enhance enterprise value.
- Global Life Sciences Practice: We are fully integrated into Sidley’s pioneering Global Life Sciences practice of over 300 lawyers worldwide. We work seamlessly across multiple legal practice areas and jurisdictions, cross-functionally tackling the issues faced by our life sciences clients in the United States and across the globe, including Europe, the UK, Switzerland, and Asia Pacific.
Contacts
Rebecca Wood
Raj Pai
Torrey Cope
Learn more about our Food, Drug and Medical Device practice.
Current Good Manufacturing Practice (GMP) compliance—and regulatory compliance more broadly—is more important than ever. Advances in drug development and drug manufacturing technologies continue to stretch and challenge the existing regulatory framework. At the same time, the broad statutory authority granted to regulators, coupled with the array of regulatory and enforcement tools available to regulators, necessitates a strategic, proactive approach to identifying and addressing potential compliance issues. Sidley’s market-leading GMP team has led, supported, and successfully resolved critical compliance matters for companies of all sizes, from start-ups to Fortune 10 companies. These matters range from resolving significant internal compliance matters, FDA 483s, and Warning Letters, to helping some of the largest pharmaceutical and medical device companies in the world address application approvability issues due to quality and facility deficiencies.
Members of our dedicated GMP team include former U.S. Food and Drug Administration (FDA) lawyers, government prosecutors, and regulatory compliance specialists, including former FDA inspectors. Our extensive capabilities, combined with a long history of engaging FDA directly on behalf of our clients, set us apart in our ability to advise our clients on identifying and mitigating risk and achieving swift resolution of pending matters.
We represent numerous clients with complicated regulatory histories. We work closely with manufacturing sites to develop action plans with effective corrective and preventative measures in response to a variety of product-related investigations. In addition, our lawyers have significant experience conducting whistleblower and internal compliance investigations related to GMP compliance issues, as well as managing related government investigations by FDA, the Department of Health and Human Services, and the Department of Justice.
Supported by Sidley’s highly ranked government investigations and litigation practices, our team is capable of continuing representation until the resolution of any action.
Our value-added services include:
- Analyzing manufacturing sites and corporate functions for GMP compliance, including aseptic processing, combination products, sterile and other high-risk devices, post-marketing surveillance, and complaint handling;
- Performing gap analyses and developing GMP work plans;
- Training personnel, from the site level to the executive suite, on GMP enforcement activity and best practices;
- Assisting with inspection readiness activities, including the development of storyboards for complex issues, as well as providing support for and conducting sessions to help subject matter experts prepare;
- Advising on recalls, supplier management, and safety reporting, with a focus on compliance with medical device reporting (MDR) and adverse drug event (ADE) requirements;
- Conducting discrepancy, non-conformance, deviation, corrective and preventive action (CAPA), and product impact investigations with detailed root cause analysis;
- Engaging with the FDA and other agencies on behalf of a firm for previous or upcoming inspections, as well as with regard to ongoing compliance commitments;
- Supporting responses to FDA 483 inspectional observations, Warning Letters, and other government inquiries;
- Performing data integrity and documentation practices investigations;
- Advising companies on identifying third-party expert consultants and compliance action plans, and supporting such activities under the attorney-client privilege; and
- Assisting with issues related to supply chain compliance, including on implementation of systems to meet obligations under the Drug Supply Chain Security Act.
Our network of offices and international reach allow us to respond promptly to government inspections and enforcement actions and to coordinate company actions plans and communications with regulatory authorities and the press worldwide. We have worked with manufacturing sites in a number of countries:
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Contacts
Raj Pai
Jim Johnson
Christopher Fanelli
Arif Noorani
Learn more about our Food, Drug and Medical Device practice.
Healthcare and life sciences companies operate under intense scrutiny, navigating a maze of global data regulations. From digital therapeutics to decentralized trials, the risks—and the stakes—have never been higher. Sidley’s Global Life Sciences (GLS) platform delivers unparalleled, industry-specific privacy and cybersecurity counsel—powered by one of the world’s leading healthcare and food, drug and medical device (FDMD) regulatory practices.
- Targeted Digital Risk and Compliance Strategy: We know health data. From PHI and clinical trial records to AI-driven platforms and RWE, we guide biopharma, medtech, diagnostics, and digital health companies through HIPAA, HITECH, state privacy laws, GDPR, and other global privacy, data protection and AI laws and regimes with precision.
- Integrated FDMD and Healthcare Insight: Sidley’s privacy team works shoulder-to-shoulder with our top-ranked FDMD and healthcare practices. Whether addressing a clinical trial breach or building a digital health platform, our counsel covers the full regulatory spectrum.
- Breach Response and Crisis Control: We lead clients through high-stakes data breaches and investigations—coordinating with forensics, PR, regulators, and law enforcement across jurisdictions to manage risk and protect brand trust.
- Boardroom-Ready Governance: We advise boards and executives on cyber oversight, disclosures, and fiduciary risk. Our custom tabletop exercises and playbooks are built for the realities of life sciences operations.
- Trusted on Tech and Innovation: From AI to wearables to cloud-based data, we help clients embed security and privacy into every stage of innovation—balancing speed with trust and compliance.
- Recognized Excellence: Ranked by Chambers USA for “litigation strength and compliance expertise,” Sidley’s 70+ lawyer global team is a go-to partner for cybersecurity and privacy in healthcare and life sciences.
Contacts
Colleen Brown
Francesca Blythe
Learn more about our Privacy and Cybersecurity practice.
Life sciences and healthcare companies face a rapidly evolving commercial landscape marked by heightened antitrust scrutiny from regulators and private plaintiffs around the world. Sidley’s Global Life Sciences (GLS) Antitrust and Competition team collaborates with clients across the industry to proactively assess and mitigate antitrust risk, navigate complex investigations and litigation, and structure business strategies and transactions to withstand global regulatory scrutiny.
Our team combines cutting-edge antitrust experience with deep industry knowledge, enabling us to offer nuanced advice and strong advocacy that reflect the scientific, regulatory, and commercial realities of the marketplace. Several of our lawyers are former Federal Trade Commission, Department of Justice, European Commission, and State Administration for Market Regulation antitrust and competition officials. They provide an insider’s perspective regarding key government policies that impact antitrust matters.
We are consistently recognized by leading legal directories and publications, including Chambers Global, The Legal 500, Global Competition Review (GCR), LMG Life Sciences, and Who’s Who Legal.
Our Antitrust and Competition team brings extensive experience to clients:
- Global Defense Against Government Investigations: Sidley defends life sciences and healthcare companies in high-stakes civil and criminal antitrust investigations and enforcement actions across the U.S., EU, U.K., and Asia. We frequently advise our clients on leniency applications, as well as help them negotiate remedies or commitments to address concerns of enforcement authorities.
- Defense in High-Stakes Litigation: Our established antitrust litigators have an impressive track record representing life sciences and healthcare clients in civil, criminal, and multi-district litigation proceedings in jurisdictions across the U.S. and internationally. In the U.S., our team routinely handles motions, hearings, trials, and appeals in federal and state courts, whether brought by enforcers or private plaintiffs. In Europe, our team has extensive experience defending clients in high-stakes litigation proceedings challenging actions of competition regulators before the General Court and the Court of Justice of the European Union and national courts.
- Merger Control and Strategic Transactions: We provide full-service antitrust counsel for mergers, acquisitions, joint ventures, and licensing transactions in the life sciences and healthcare industries. We handle global merger control filings and advise on substantive antitrust risks, including implications of new filing thresholds, “dynamic” theories of harm, managing extended periods for pre-notification discussions, managing large requests for—and heavy scrutiny of—internal company documents, and negotiating remedy packages.
- Sector-Specific Antitrust Advice: We regularly provide antitrust advice on government contracting, multi-jurisdictional pricing negotiations, discount and rebate schemes, regulatory exclusivity issues, “product hopping,” product advertising, supply chain management (including stock allocation schemes), life cycle management strategies, as well as distribution, licensing, supply, co-marketing, research and development, and other types of commercial agreements. We also assist life science companies and trade associations in implementing regional and global antitrust compliance programs aimed at avoiding involvement in public authority investigations and civil litigation.
Contacts
Anne Robert
Benjamin Nagin
Benjamin Mundel
Patrick Harrison
Vadim Brusser
Steve Horowitz
Learn more about our Antitrust and Competition practice.
In an era of geopolitical volatility, supply chain disruption, and rapidly evolving global regulation, life sciences companies must navigate international trade, customs, export controls, and economic sanctions rules with care and confidence. Sidley’s Global Life Sciences (GLS) platform connects sector-specific insight with elite global trade counsel to help companies manage risk, maintain market access, and seize opportunity across borders.
Sidley’s International Trade practice delivers:
- Life Sciences-Focused International Trade Strategy: From active pharmaceutical ingredients and biologics to medical devices and controlled technology, we advise life sciences clients on import/export compliance, market access barriers, and cross-border regulatory regimes. We help clients align global operations with U.S., EU, and multilateral trade policy that impact product movement, pricing, and distribution.
- Customs and Supply Chain Guidance: We support manufacturers, CDMOs, and distributors in navigating tariffs, customs classification, valuation, and origin issues—especially critical as companies navigate reshoring, diversification, and de-risking of global supply chains. Our team helps secure favorable rulings, mitigate duties, and resolve audits and investigations at the border.
- Economic Sanctions and Export Controls: Sidley advises on U.S. and EU economic sanctions, export control regimes (e.g., EAR, ITAR), and blocked party screenings. We support life sciences companies with compliance programs, licensing strategies, enforcement defense, and crisis response when engaging in sanctioned jurisdictions or dealing with dual-use technologies.
- Multilateral Trade and Government Advocacy: Our team represents clients before the U.S. Trade Representative (USTR), EU trade regulating bodies, and the World Trade Organization (WTO), advocating on issues such as discriminatory regulatory frameworks, intellectual property enforcement, and cross-border digital health trade barriers.
- Recognized Excellence: Sidley is the only team ranked Band 1 for International Trade in every major jurisdiction for Chambers & Partners: Global-wide, Europe-wide, Asia-Pacific, and USA (2017-2025). Our International Trade practice is recognized globally for helping clients succeed at the intersection of international law, policy, and business.
Contacts
Learn more about our Global Arbitration, Trade and Advocacy practice.
Advising on the full scope of regulatory and compliance matters, we can offer you a holistic legal approach that will smooth your path as you navigate industry changes, technological advances, market demands and policy hurdles.
