Barbara A. Binzak Blumenfeld, Ph.D. focuses her practice on clients whose products are subject to Food and Drug Administration (FDA) regulations, including drugs, biologics, medical devices, foods, dietary supplements, medical foods, and cosmetics. Barbara advises clients on a wide variety of development and approval issues, including:
- Requirements for new drug applications (NDAs), abbreviated new drug applications (ANDAs), over-the-counter (OTC) drug monographs and drug labeling.
- Investigational new drug application (IND) and biologics license application (BLA) requirements for biologic products, such as stem cells.
- Regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps).
- Food, dietary supplement, and medical food labeling and regulatory issues.
- Premarket approval (PMA) application and 510(k) premarket notification requirements for medical devices.
- Regulation of combination products.
- Planning for drug and medical device reimbursement.
Since joining Buchanan in March 2003, Barbara has capitalized on her unique background, integrating science and bioethics into her legal practice. She has published on topics that include new drug/generic drug life cycle tensions, INDs, medical foods, and mobile medical applications. Barbara has also spoken and moderated panels on HCT/Ps, the Drug Supply Chain Security Act (DSCSA), and risk evaluation and mitigation strategies (REMS).
My training in molecular biology, biomedical ethics, and the law converge daily to allow me to really understand my clients’ technologies. As a result, I can better communicate with my clients because I “speak their language.” This background also allows me to anticipate the kinds of questions that FDA regulators may have about those technologies.
Barbara has served as a working group member on 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) since beginning her legal practice, and recently concluded her service on the Board of Directors. She is now a member of the Editorial Advisory Board of FDLI's Food and Drug Law Journal . In July 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. Barbara earned a dual J.D./M.A. degree in biomedical ethics following her Ph.D. During that time, she served as a research assistant to Dr. Daniel Callahan of The Hastings Institute in New York state on his 2003 book, What Price Better Health? Hazards of the Research Imperative . She interned at NIH in the National Human Genome Research Institutes (NHGRI's) Office of Policy, Planning and Communication. Barbara was also the executive articles editor of her law school's health journal, Health Matrix: Journal of Law-Medicine .