Susan Lee

Susan Lee’s practice focuses on the U.S. Food and Drug Administration’s regulation of pharmaceuticals and biological products. Susan counsels clients on a broad range of FDA legal and regulatory matters, with particular areas of expertise and interest in advertising and promotion issues; the design and conduct of clinical trials; approval standards for new products; and the FDA-related considerations that arise in the context of acquisitions, collaborations, licensing arrangements, and other types of transactions in the pharmaceutical and biotechnology sector.