For decades, Arnold & Porter LLP's FDA and Healthcare practice has been a leader in helping pharmaceutical, biotechnology, medical device, and diagnostic companies, as well as other healthcare entities, respond to complex regulatory and compliance challenges in the US and Europe. We assist our clients in routine counseling matters, resolving their issues and concerns and supporting key business operations, as well as in the most complex crises-all with an eye on their long-term business and product goals. Our practice also has substantial experience in the regulatory issues faced by food, dietary supplement, and cosmetic product companies.
Unlike many firms that have separate FDA and healthcare practices, and even divisions within the FDA practice, Arnold & Porter believes that it is important for all of the lawyers and other professionals in our global FDA and Healthcare practice to understand all aspects of how biomedical products and services get to the marketplace, how governments and private entities pay for such products, how to develop and maintain compliant systems to avoid problems, and how to respond to investigations and enforcement proceedings. We instill this approach throughout our practice, including the cross-training of our associates.
Our teams in the US and Europe include experienced attorneys, many of whom have previous government agency experience-medical doctors, scientists, and public policy specialists. These professionals work together to provide our clients with seamless, comprehensive, and sophisticated analyses, and strong and zealous advocacy.
For a comprehensive overview and analysis of significant regulatory changes in FDA law, please read our recently published Reference Guide to the Food and Drug Administration Safety and Innovation Act.