미국 FDA 규제

Research & Development: We work closely with our clients from the earliest stage of a product’s life cycle – research and development. Our firm’s extensive work representing academic medical centers, research institutions, and universities, as well as global life sciences companies, provides a unique perspective when counseling clients on pre-clinical and clinical research and development activities. We also advise on clinical research, including FDA Investigational New Drug (IND) and Investigational Device Exemption (IDE) requirements, human subjects protections, compliance with Good Clinical Practice (GCP) standards, clinical trial registration and results reporting, and adverse event reporting. We help clinical sites and research sponsors develop and implement research policies, procedures, and templates to ensure compliance with legal requirements, protect business interests, and facilitate research activities.

Regulatory Strategy & Product Approvals: We guide clients through every stage of the regulatory approval process, from initial strategy development to final market authorization. Our team includes counsel with significant experience related to leveraging development and approval incentives, selecting optimal regulatory pathways, preparing for advisory committee meetings, managing inspection readiness, responding to complex inquiries from regulators like the FDA, and appealing adverse regulatory decisions.

Life Cycle Management: Strategic, informed legal advice is essential to secure and extend market exclusivity to qualifying products. In the U.S., we advise on core exclusivity frameworks under the Hatch-Waxman Act; the Orphan Drug Act; the pediatric exclusivity provisions of the Federal Food, Drug, and Cosmetic Act (FDCA); and the Biologics Price Competition and Innovation Act (BPCIA).

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Pharmaceuticals: We guide the world’s leading multinational pharmaceutical manufacturers, as well as mid-size and start-up drug companies, in navigating FDA and global regulatory requirements spanning the product life cycle. We help clients craft initial regulatory strategies, secure product approvals, navigate life cycle planning, and ensure compliant manufacturing and marketing operations. Our team regularly advises on Risk Evaluation and Mitigation Strategies (REMS), pharmacovigilance obligations including adverse event reporting and post-market surveillance, and Good Manufacturing Practices (GMP), including facility inspections and responses to FDA Form 483 observations and warning letters. We also represent pharmaceutical companies in disputes with regulators and competitors, assist with internal investigations, and design robust compliance programs to mitigate enforcement risk.

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Our team advises global manufacturers, mid-sized companies, and start‑ups across the full MedTech spectrum, from traditional devices and diagnostics to digital health, software as a medical device (SaMD), artificial intelligence/machine learning (AI/ML)‑enabled technologies, and combination products. We guide clients through every phase of the product life cycle, including product classification and pre-submission strategy, bench testing and performance standards development, design verification and validation, clinical study design and execution, product clearance and approval, labeling and promotional compliance, quality system and manufacturing oversight (including FDA’s Quality Management System Regulation (QMSR)/ISO 13485 alignment), post-market surveillance, and enforcement matters such as Warning Letters, recalls, and complex litigation. Clients benefit from our integrated strengths in device transactions, research funding, reimbursement and health care regulation, privacy and cybersecurity, and government investigations – delivering counsel grounded in the commercial and regulatory realities of today’s market.

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We regularly counsel global pharmaceutical, biologics, and medical device companies, as well as drug compounders, on a wide range of manufacturing and quality issues. Key areas of focus include good manufacturing practice (GMP) and Quality Management System Regulation (QMSR) requirements, industry quality standards and guidelines, related interactions with regulators including the FDA, product recalls, internal compliance investigations, and contractual relationships with suppliers and other third parties involved in manufacturing. Our team is highly experienced in helping companies respond to FDA Warning Letters and Form 483s, and in negotiating injunctions and consent decrees with the FDA and the U.S. Department of Justice. We also advise global life sciences companies on establishing proper supply chain controls and responding to import alerts and detentions relating to alleged quality deficiencies. 

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We have significant experience advising digital health companies and other institutions that create and employ digital health and AI technologies in the healthcare context and thus are subject to regulation by the FDA and regulatory authorities in other jurisdictions. We have advised on myriad considerations, including regulatory classification of software as a medical device by the FDA, artificial intelligence/machine learning (AI/ML)-based software regulation, real-world evidence/real-world data regulation (RWE/RWD), device clearance and approval, cybersecurity requirements, and more. Our team frequently collaborates with colleagues in the firm’s privacy and data security, intellectual property, and health care compliance practices to serve our digital health clients around the world. Our breadth of experience and in-depth knowledge of key legal, regulatory, and policy issues posed by the rapid convergence of technology, health care, and life sciences makes us a valuable partner for any participant in this arena. 

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Food & Dietary Supplements: Our attorneys have extensive experience counseling food and dietary supplement companies in all areas of FDA regulation, including:

• Dietary Supplement Health and Education Act (DSHEA)
• Good Manufacturing Practices
• Reportable food registry requirements
• Bioterrorism Preparedness and Response Act
• Food Safety Modernization Act (FSMA)
• Food Allergen Labeling and Consumer Protection Act
• Color additives and development of their structure, function, nutrient content, and health claims
• Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

Drawing on resources from our offices across the world, we regularly represent food and beverage companies in internal investigations, litigation, and government enforcement matters relating to the Federal Food, Drug, and Cosmetic Act; the Foreign Corrupt Practices Act; and financial statement disclosure and other securities enforcement issues.

Cosmetics: Cosmetics companies frequently encounter regulatory issues, including issues related to manufacturing, labeling, and promotional claims. We routinely counsel clients on the dividing line between cosmetic claims and drug claims, Federal Trade Commission (FTC) substantiation requirements, cosmetic appliance issues, import detentions and alerts, social media policies, combination product and co-packaging, compliance with MoCRA, and related issues.

Our attorneys are widely recognized authorities in the dynamic laws and policies governing the advertising and promotion of products from prescription and over-the-counter (OTC) drugs to medical devices, food, dietary supplements, and cosmetics. We deliver practical, risk-based advice on how to optimize product communications while complying with FDA, FTC, state consumer protection laws, and other regulatory requirements and mitigating risk. We routinely advise clients on promotional, disease awareness, and scientific exchange initiatives, and we conduct rigorous copy reviews of promotional and medical materials.

We have deep experience with FDA promotional rules and the First Amendment. We have been involved in every major First Amendment litigation involving the FDA’s regulation of manufacturer communications. We frequently help clients respond to Warning Letters and enforcement actions from the FDA, FTC, and other comparable authorities, as well as to trade complaints from competitors. We also partner with our clients to help ensure that their competitors are held to the same standards.

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The firm’s Asia-Pacific life sciences practice, with a hub in Singapore, delivers cutting-edge transactional, regulatory, compliance, and enforcement counsel to companies operating in the region. We represent leading pharmaceutical, biotechnology, medical device, and consumer health companies – as well as investment banks, venture capital, and private equity investors – to structure, negotiate, and consummate high-impact transactions that advance innovation and accelerate growth. With deep regional knowledge and an integrated cross-border approach, we guide clients through the full deal life cycle, from early strategic alignment and diligence through execution and integration. On the regulatory front, we advise on the full spectrum of good practice (GxP) compliance, pricing and reimbursement, labeling, advertising and promotion, pharmacovigilance and product safety, and government investigations. Our team regularly assists clients in responding to inquiries and enforcement actions by authorities such as China’s National Medical Products Administration (NMPA), the National Health Commission (NHC), and the State Administration of Market Regulation (SAMR), as well as the U.S. FDA. 

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Ropes & Gray’s European life sciences regulatory practice, based in London and Dublin, advises life sciences companies across the UK and EU on complex, cross-border transactional, regulatory compliance, and enforcement matters. The team regularly handles litigation, internal investigations, and public policy matters affecting the life sciences industry. The group also represents clients before UK and European regulatory bodies on product approvals, market access, advertising and promotion, manufacturing, and safety vigilance.

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Drawing on deep knowledge of all areas of drug and medical device pricing regulation, Ropes & Gray’s cross-practice pricing team provides life sciences companies with strategic business and legal advice on existing and proposed government approaches to prescription drug and medical device pricing and price reporting. We also advise clients on initiatives to increase FDA and FTC activity to address alleged “gaming” of generic drug approvals. When pricing or price reporting issues need to be litigated, we draw on our deep bench of civil and criminal litigators. Our team frequently works as leading counsel on headline pharmaceutical and medical device acquisitions and has supported the successful regulatory and market launch of first-in-class, life-saving products. We also advise on commercial market strategy to promote robust access to and appropriate reimbursement of drugs and medical devices.

We frequently assist our renowned M&A, capital markets, and IP transactions colleagues with regulatory due diligence, advising on innovative deal structures and their regulatory implications, and drafting key contractual provisions in highly complex life sciences transactions, licensing deals, and collaborations, including some of the most prominent deals in this sector. For example, we regularly advise on complex issues such as the degree of regulatory cooperation and coordination between parties, clinical and regulatory milestones in collaboration agreements, change of ownership issues related to complex carve-outs, and regulatory provisions in ancillary agreements, including transition services agreements and pharmacovigilance agreements, among others. Ropes & Gray is unique in our ability to handle an entire transaction under one roof, drawing on our experienced colleagues in various practice groups, providing a one-stop shop, and eliminating the burden of working with multiple, independent teams. 

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We are well versed in all types of post-market enforcement matters, ranging from advisory actions such as FDA Warning Letters to formal actions such as withdrawals of product approvals, product seizures, injunctions and consent decrees, recalls, import alerts, denial of export certificates, civil money penalty hearings, and criminal prosecutions. We also frequently seek to uphold the interests of clients by bringing administrative or legal actions directly against the FDA and other regulatory authorities and government agencies, and we also routinely defend our clients in litigation initiated by competitors. In addition, we regularly counsel biopharmaceutical and medical device companies on internal investigations, as well as government False Claims Act investigations predicated on allegations related to underlying FDA regulatory violations.

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