Etan J. Yeshua Associate 202-737-9638
Etan J. Yeshua

Overview

Mr. Yeshua provides counsel on an array of matters involving food, drug, and cosmetic regulation. He has advisesd clients in areas of pharmaceutical product development including clinical trial issues, advisory committee meetings, Orphan Drug and Fast Track designations, and special protocol assessments, and formal dispute resolutions. He also works with food, cosmetic and over-the-counter (OTC) drug companies on various issues including product development, labels and labeling, advertising and promotion (including social media and mobile platforms), menu labeling requirements under the Patient Protection and Affordable Care Act, as well as FTC regulation, NAD, and ERSP review.

Before joining the firm in 2012, Mr. Yeshua was an adjunct professor at the Georgetown University Law Center, where he was awarded Georgetown’s Stabile Fellowship and co-taught a course in the regulation of OTC drugs, cosmetics, and dietary supplements while advising a consumer advocacy organization on FDA regulatory matters. He represented the organization before FDA, drafted regulatory comments and FOIA requests, and provided strategic advice on food policy initiatives.

Mr. Yeshua is a graduate of the Georgetown University Law Center and has studied Chinese administrative law at Tsinghua University Law School in Beijing, China. He also served as an analyst in the New York City Police Department Commissioner’s Office of Management Analysis and Planning.

Education & Admissions

Education

J.D. Georgetown University Law Center
B.A. Philosophy, Columbia University
B.A. Comparative Bioethics, Jewish Theological Seminary

Admissions

District of Columbia
Maryland

Experience

Drug and Biologic Development
Conducts due diligence related to corporate transactions and SEC filings.
Drafts formal meeting and formal dispute resolution requests, and prepares sponsors for meetings with FDA.
Provides strategic advice in advance of Advisory Committee meetings.
Prepares requests for orphan product designation.

GMP Compliance and Facility Inspections
Counsels clients on responding to FDA inspections and warning letters.
Facilitates internal investigations of manufacturing practices and facilities.

Foods, OTC Drugs, and Cosmetics
Reviews product labels, labeling, and other promotional material for compliance with FDA and FTC requirements and advises on other legal and regulatory risks.
Advises on the use of online, mobile, and social media platforms as promotional tools.
Drafts challenges and represents clients before the NAD and ERSP regulatory programs.

Recent Speaking Engagements

  • Bronchiectasis Physician/Patient Conference, Ask the Experts: Industry Q & A, May 19, 2017
Education

J.D. Georgetown University Law Center
B.A. Philosophy, Columbia University
B.A. Comparative Bioethics, Jewish Theological Seminary

Admissions

District of Columbia
Maryland

Practice Areas
Industries
FDA Regulatory Categories