Chris has extensive experience in the regulation of food, drugs, biotechnology and medical devices by the Food and Drug Administration and other federal and state agencies. He has counseled and represented clients in cases concerning product development and manufacture, preclinical and clinical trials, premarket clearance and approval, citizen petitions and post-market issues and procedures such as inspections, recalls and enforcement actions.
Chris also has handled a wide variety of compliance and litigation matters pertaining to product labeling and promotion, including proceedings before the National Advertising Division of the Council of Better Business Bureaus and the Federal Trade Commission. He also regularly performs transactional work related to FDA-regulated products, including material and service contracts, licensing and due diligence of major deals.
Chris also has comprehensive experience in patent litigation and other complex disputes. He has represented some of the world’s largest pharmaceutical, medical device, consumer product and technology companies in patent infringement, trade secret and product liability lawsuits and alternative dispute resolution processes throughout the country. In addition, he has conducted patent proceedings before the United States Patent and Trademark Office and has drafted various forms of federal legislation covering food and therapeutic products.
Drawing on this range of experience, Chris works closely with clients to develop and implement their most effective business strategies for successfully navigating the complexities of the regulatory environment, procuring and licensing intellectual property and either avoiding or deriving maximum value from litigation, administrative proceedings and other forms of dispute resolution.
Chris is a Fellow of the American College of Legal Medicine and a member of the American Medical Association, Food and Drug Law Institute, American Intellectual Property Law Association and American Health Lawyers Association. He has taught patent and FDA law at the University of Pennsylvania and served on the board of trustees of the Pennsylvania Medical Society. He has spoken and written extensively on intellectual property and regulatory issues, including those concerning Hatch-Waxman, biosimilars and medical devices.Chris has long served as a pro bono lawyer with the Support Center for Child Advocates, providing legal representation and social service advocacy for abused and neglected children in his home town of Philadelphia.
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