FDA Regulatory

Overview

A clear understanding of FDA regulatory requirements is essential to the success of a life sciences company. Our Washington, D.C.-based FDA regulatory team includes seasoned lawyers knowledgeable in all areas of FDA regulation. The team’s varied backgrounds bring a breadth of perspectives to the practice which includes attorneys who have worked at the FDA, as in-house counsel at life sciences companies and as key policy advisors in Congress.

Our clients include many of the world’s leading pharmaceutical and biologics companies, medical device manufacturers and cosmetics, food and dietary supplement companies and distributors. We offer comprehensive services, including:

• Regulatory Strategy, Product Development & Product Approvals
• Advertising & Promotion
• Post-Approval Compliance 
• FDA Enforcement Actions & Litigation 
• Congressional Investigations & Public Policy
• Due Diligence Reviews & Transactional Support

As part of our multidisciplinary life sciences group, our FDA regulatory team has a broad view of the commercial and regulatory forces affecting life sciences companies. In addition to traditional regulatory counseling and administrative litigation, we advise clients on corporate and transactional matters, government enforcement investigations, compliance program design and implementation, and FDA-related intellectual property analyses and litigation.

We also provide counseling to clients regarding other related government agencies, including the Federal Trade Commission (FTC), Consumer Product Safety Commission (CSPC) and the U.S. Department of Agriculture (USDA). Our advertising practice also includes representation of clients subject to challenges brought before the National Advertising Division of the Better Business Bureau (NAD). For more information about our services, please contact one of our FDA attorneys.