About Daniel A. Kracov

Daniel A. Kracov is a partner and is co-chair of the life sciences and healthcare regulatory practice. For decades, he has been one of the foremost Food and Drug Administration lawyers in the United States, and his experience in critical regulatory matters has been widely recognised within the industry. His practice focuses on assisting pharmaceutical, biotechnology, medical device and diagnostic companies – including emerging companies, trade associations, and global manufacturers – in negotiating challenges relating to the development, approval and marketing of FDA-regulated products. In addition to day-to-day counselling on regulatory strategies and concerns, he regularly handles product- and compliance-related government and internal investigations, the development of global corporate compliance programmes, and due diligence in financings, mergers and acquisitions. He has widely recognised experience in biomedical public policy matters, including Congressional investigations and advising on FDA-related legislation.