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Life Sciences

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Practice Group Leader

Robert B. Fleming, Jr.

Attorneys

Lura Hess Bechtel

Elizabeth K. Buscaglia

George J. Eydt

Michael J. Flanagan

Amy L. Goerss

Julia M. Hilliker

Bethany J. Hills

Ranjana Kadle, Ph.D.

John D. Lopinski, Ph.D.

Michael E. Maxwell

Michelle Merola

Daniel C. Oliverio

Richard B. Raymer

David M. Stark

Ellen V. Weissman

As a life sciences company, your business faces extra hurdles along the route to the marketplace, and at times you may need assistance to navigate agency regulations and steer clear of enforcement action. Recent regulatory changes, increased scrutiny of marketing and pricing issues, and complex intellectual property issues require realistic and effective strategies to maintain a competitive edge.

Hodgson Russ has broad experience coupled with a full range of legal services to help you promote your product lines and advance your business. Our Life Sciences Group is a multidisciplinary team of attorneys experienced in regulatory compliance, unfair competition, product liability risk control, intellectual property, and enforcement. We advise on traditional and special regulatory issues and can help you participate in agency rulemaking, respond to federal and state administrative enforcement actions, and handle civil and criminal litigation. When challenging issues arise, Hodgson Russ attorneys provide sophisticated counseling and advice to help protect your business’s operations while maintaining your positive relationship with the FDA. Our attorneys have extensive experience representing clients before the FDA Consumer Product Safety Commission (CPSC), Drug Enforcement Agency (DEA), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), and the U.S. Customs Service.

We assist life science businesses with:

• Enforcement actions, including product liability, recalls, seizures, FDA warning letters, and other notices of alleged violation
• Facilities audits and FDA inspections
• Cross-border issues, including assisting Canadian companies with bringing their products to the United States
• Cross-border and transfer tax issues
• Mergers and acquisitions
• Corporate financing
• Licensing and collaborative agreements
• Licensing, patent, or trademark protection for your product
• Regulatory and clinical research compliance
• Third-party, government, and health insurance reimbursement
• Recalls and corrective actions in conjunction with product liability
• Legislative and regulatory advocacy and policy development
• Compliance advice and white-collar criminal defense
• Compliance training and conduct audits
• Foreign Corrupt Practices Act (FCPA) compliance plans

Medical Device, Drug, and Biologic Experience

Our attorneys have specific experience in medical device, drug, and biologics products and can help you navigate challenges including:

• Determining proper device classification
• Complying with cGMP (current good manufacturing practices)
• Obtaining investigational device exemptions (IDE)
• Advising on medical device reporting (MDR) strategy and compliance
• Advising on medical device pre-market applications, including NDA, ANDA, 510(K), and PMAs
• Advising on drug advertising, labeling, and promotional material, including Web sites and direct-to-consumer advertising
• Addressing antitrust implications of bringing pharmaceuticals to market
• Obtaining new drug approvals, including filing NDAs, ANDAs, and veterinary applications
• Assisting in over-the-counter (OTC) drug manufacturer registration, product listing, and marketing compliance
• Meeting Prescription Drug Marketing Act (PDMA) requirements

Our Life Sciences Group works with other attorneys in the firm to provide core interdisciplinary counsel to our life sciences clients. This provides our clients with appropriate counsel for each stage of business development, including corporate attorneys specializing in mergers and acquisitions; finance attorneys with venture capital experience; business and regulatory attorneys capable of preparing appropriate licensing, distribution arrangements, and antitrust compliance advice; cross-border attorneys with extensive experience in international tax, import and export, and international business development; and real estate practitioners who can advise on leasing or real property investment.