FDLI Introduction to Biologics and Biosimilars Law and Regulation - Novel Products and Situations: Beyond the Traditional BLA

Oct 3 2018

Barbara Binzak Blumenfeld, Shareholder in the firm's FDA & Biotechnology section, will present at the Food and Drug Law Institute (FDLI) Introduction to Biologics and Biosimilars Law and Regulation course in Washington, D.C. Her presentation, "Novel Products and Situations: Beyond the Traditional BLA," will focus on the FDA regulation of human cells, tissue and cellular- and tissue-based products (HCT/Ps); the distinction between FDA regulatory oversight of products versus the physician practice of medicine; and FDA's precision medicine initiatives. Barbara regularly counsels clients in each of these areas.