Daniel A Kracov is co-chair of the life sciences and healthcare regulatory practice. In 2020, he was named Pharmaceutical Regulatory Attorney of the Year by LMG Life Sciences. For decades, he has been one of the foremost Food and Drug Administration (FDA) lawyers in the country, and his expertise in critical regulatory matters has been widely recognised by Chambers, The Legal Times, Best Lawyers in America and other publications. A particular focus of his practice is assisting pharmaceutical, biotechnology, medical device and diagnostic companies, including start-up companies, trade associations and large manufacturers, negotiating challenges relating to the development, approval and marketing of FDA-regulated products. He also has extensive experience in matters relating to foods, dietary supplements and cosmetics.
The Pharmaceutical Intellectual Property and Competition Law Review provides a practical overview of pharmaceutical intellectual property issues, including patent linkage and exclusivities, and related competition concerns. With a focus on recent developments, it is a useful tool for managing global risks in this area – analysing the key elements of the relevant legal and regulatory regimes across major jurisdictions worldwide.