Barbara A. Binzak Blumenfeld, Ph.D. is Co-Head of the FDA & Biotechnology Section.  Barbara helps clients make and execute on strategic decisions about FDA-regulated products. She leverages her unique background, integrating science and biomedical ethics into her legal practice to create true value for her clients. Each client has unique goals, and Barbara formulates a regulatory strategy that is individualized to each one.

Barbara assists clients with FDA regulatory matters arising before, during, and after product approval and marketing. She has worked with clients on virtually all categories of FDA-regulated products, including drugs, biologics and biosimilars, medical devices, foods, and combination products.  She also works closely with Buchanan’s IP attorneys to create a holistic IP/FDA strategy that takes into account the company’s patent portfolio, any FDA patent listings, and FDA-granted regulatory exclusivity.