is a partner and co-chair of the Arnold & Porter Life Sciences and Healthcare Regulatory practice. For decades, he has been one of the foremost FDA regulatory and compliance lawyers, and his expertise in critical regulatory matters has been widely recognised. A particular focus of his practice is assisting pharmaceutical, biotechnology, medical device and diagnostic companies – including start-up companies, trade associations and large manufacturers – negotiate challenges relating to development, approval and marketing. He also has extensive experience in investigations, compliance and enforcement matters, as well as issues relating to foods, dietary supplements and cosmetics.
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