Eitan N. Bernstein
Eitan Bernstein, an associate in the Washington, D.C. office, specializes in regulatory matters involving the Food and Drug Administration (FDA) and transactional matters involving the life sciences industry. In particular, Mr. Bernstein's practice focuses on counseling pharmaceutical, medical device, food, dietary supplement and other related industry clients with respect to regulatory issues. He has advised on matters involving pre-market development strategies, FDA submissions, regulatory inspections and product recalls, and has assisted in the review of clinical trial agreements for both pharmaceutical and medical device companies.
Mr. Bernstein earned his Master of Public Health degree from the Harvard School of Public Health and his law degree from the Harvard Law School. During his Master’s program, Mr. Bernstein interned with the chair of the Joint Committee on Public Health in the Massachusetts Senate. In addition to his legal and public health training, Mr. Bernstein holds a Bachelor of Science degree in biological sciences from Yale University.
- “Biological Products: New FDA Draft Guidance Sheds Light on Reference Product Exclusivity,” Pharmaceutical Law & Industry Report, 2014
- “The Regulation of Follow-On Biologics: FDA Authority and Implementation,” The Food and Drug Law Institute, 2013