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).