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 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 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 also 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.

The attorneys in our Life Sciences Group frequently lecture and write on topics in their specific areas of concentration, including health law, FDA regulatory law, fraud and abuse, health care reimbursement, intellectual property, HIPAA, international licensing, and technology, medical device, and biotechnology transactions. They also founded and regularly contribute to GatewayFDA—a life sciences blog featuring analysis, commentary, and resources to help foreign pharmaceutical and medical device companies make sense of ever-evolving FDA regulations and U.S. legal issues that may complicate bringing an FDA-regulated product or service to market in the United States. For more information, or to subscribe to GatewayFDA’s RSS feed, visit www.gatewayfda.com.

Web design and CMS by Algonquin Studios.

Life Sciences

Practice Group Leader

Attorneys

We assist life science businesses with:

Medical Device, Drug, and Biologic Experience

Related Links