Barbara A. Binzak Blumenfeld, Ph.D., helps clients make and execute on strategic decisions about FDA-regulated product approvals. She leverages her unique background, integrating science and biomedical ethics into her legal practice to create true value for her clients. For example, Barbara works closely with Buchanan’s IP attorneys to create a holistic IP/FDA strategy that takes into account the company’s patent portfolio, FDA Orange Book listings, and FDA-granted regulatory exclusivity.
Barbara assists clients with FDA regulatory matters arising before, during, and after product approval and marketing. She has worked with clients on virtually all types of FDA-regulated products, including drugs (human and veterinary), biologics, regenerative medicine (cell and gene therapies), medical devices, foods (human and veterinary), and combination products.
Key examples of Barbara’s experience include:
- Guiding a physician-investigator through the pre-investigational new drug application (IND) meeting and IND submission processes for a regenerative medicine product.
- Advising the sponsor of a new drug application (NDA) regarding the availability of three-year marketing exclusivity based on studies supporting the application.
- Assisting the sponsor of an abbreviated new drug application (ANDA) with FDA’s notification that it refused to receive a first filer ANDA containing a Paragraph IV patent certification.
- Working with a European company to convert its CE-mark dossier for a medical device into a cleared 510(k) notification.
- Performing due diligence on a stem cell company for an investment group.
- Counseling a food producer on compliance with the Food Safety and Modernization Act (FSMA).
- Preparing a request for designation (RFD) with FDA’s Office of Combination Products regarding product regulation as a drug or a medical device.
Barbara has published and presented on numerous FDA-related topics, including 505(b)(2) NDAs; INDs; medical foods; human cells, tissues, and cellular and tissue-based products (HCT/Ps); the Drug Supply Chain Security Act (DSCSA); and risk evaluation and mitigation strategies (REMS).
My training in science, biomedical ethics, and the law allow me to truly understand my client’s technologies. This results in better communication with clients because I speak their language. Clients look to me to be able to translate their scientific discoveries into an actionable FDA strategy.
Barbara has also served on various professional boards and groups. She was a working group member for a grant awarded to the University of Maryland by the National Institutes of Health's (NIH's) Human Microbiome Project for the study of the federal regulation of probiotics. She has held numerous positions within the Food and Drug Law Institute (FDLI), including serving as a member of the FDLI Board of Directors. In 2016, Barbara was named to her alma mater Cardinal Stritch University's College of Arts and Sciences Advisory Committee.
Prior to law school, Barbara earned her Ph.D. in molecular biology, focusing her research on the study of genes encoding proteins involved in amino acid and lipid metabolism. She then pivoted her focus from the lab to the law, where she could use her bench science to further a career in food and drug law. Today, Barbara and her husband enjoy time with family and friends, listening to live jazz music, and cruising to far-off destinations.
Case Western Reserve University, J.D., 2003, cum laude, Certificate in Health Law
Case Western Reserve University, M.A., 2003, Biomedical Ethics
Mayo Graduate School, Ph.D., 1999, Molecular Biology
Cardinal Stritch University, B.A., 1993, magna cum laude, Biology, Chemistry Minor
- Washington DC
American Bar Association
Maryland State Bar Association
District of Columbia Bar
Member, Austern Writing Awards Committee, Food and Drug Law Institute
Member, Sigma Xi, The Scientific Research Society
Member, College of Arts and Sciences Advisory Council, Cardinal Stritch University
Member, Regulatory Affairs Committee, BIOCOM
Member, Medical Device Committee, BIOCOM
Member, Federal Committee, BIOCOM