Regulation has posed increased challenges for the life sciences industry. The emerging role of artificial intelligence and the ongoing change in political landscape continue to create uncertainty in the industry. Our highly regarded FDA and Life Sciences team strategically guides life sciences companies through the entire scope of the evolving framework of FDA and CMS.    We assist our clients on the entire spectrum of FDA-regulated products, including pharmaceuticals, biotech, devices, food, supplements, cosmetics, and tobacco, through all aspects of U.S. and EU regulatory compliance challenges. We draw from decades of industry experience to work through every issue at every stage of a product’s life cycle.

Manufacturers, investors, and other regulated entities value our practical advice and relationships with U.S. state, federal and EU regulatory bodies. The team’s 40+ lawyers and consultants have held senior positions in government, industry, academia and the medical profession. Through benchmarking from over 350 industry clients, our annual marquee conferences, and cutting-edge webinars and client alerts, our attorneys share and analyze key developments and practical insights on the most relevant and novel issues in the life sciences space.

Our regulatory attorneys draw on decades of experience to successfully guide clients through:

Clinical trial matters, such as IDE and IND submissions and BIMO inspections	Government price reporting obligations and associated commercial and strategic implications
FDA approval process and premarket clearance	Reimbursement -- coverage, coding and payment
FDA requirements and policies applicable to pharma, device, cosmetic, and food labeling and promotion	Fraud and abuse compliance, including the FCA, AKS, FCPA, AdvaMed and PhRMA codes, and physician consultant arrangements,
FDA inspections, Warning Letters, and administrative litigation (appeals of adverse FDA decisions)	Federal Physician Payments Sunshine Act and similar state transparency laws
FDA administrative, civil, and criminal enforcement actions	Due diligence evaluations on behalf of life sciences companies, private equity funds, and venture capital firms
Investigations and all related interactions with FDA, CMS, OIG, and DOJ	Complex food regulatory matters and food false advertising litigation

We are distinguished not only by our outstanding attorneys, but also by our industry consultants, including physicians and former senior FDA officials focused on quality and safety, good manufacturing practices, inspections and product approvals. Our consultants work under privileged legal supervision to provide companies with integrated medical and technical assessments and recommendations.

Our team in the EU focuses on EU and national (French, Belgian and German) issues associated with the legal requirements of the pharmaceutical, biologic, medical device, cosmetic and food industries. They advise life sciences clients on successful strategies for addressing significant EU policy developments and the EU regulatory regimes. The EU team represents our clients in litigation cases before German and European courts, including the General Court and the Court of Justice of the European Union, and in investigations.

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