Eitan Bernstein, an associate in the Washington, D.C. office, focuses his practice on 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.
- “Introduction to Drug, Biologics, and Biosimilars Law and Regulation,” The Food and Drug Law Institute, July 2019
- “Traditional Meat and Dairy Foods and Innovative Substitutes: Key Regulatory and Enforcement Issues,” The Food and Drug Law Institute, March 2019
- “FDA Issues Draft Guidance on Biosimilar Interchangeability,” Latham & Watkins Client Alert, January 2017
- “Biological Products: New FDA Draft Guidance Sheds Light on Reference Product Exclusivity,” Pharmaceutical Law & Industry Report, 2014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
Mr. Bernstein’s representative experience includes assisting in the representation of:
- A medical device company in the appeal of a Not Approvable Letter before the Deputy Director of the Center for Devices and Radiological Health
- A pharmaceutical company in the appeal of a determination by the Small Business Administration that the company was other than a small business, requiring payment of FDA user fees
- A medical device company in responding to the receipt of an FDA form 483 notice of inspectional observations
- A medical device company in drafting a Clinical Laboratory Improvement Amendments of 1998 (CLIA) waiver request
- A pharmaceutical company in crafting a communications strategy to avoid potential off-label promotion