Etan J. Yeshua
J.D. Georgetown University Law Center
B.A. Philosophy, Columbia University
B.A. Comparative Bioethics, Jewish Theological Seminary
District of Columbia
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Mr. Yeshua provides counsel on an array of matters involving food, drug, and cosmetic regulation. He has advised clients in areas of pharmaceutical product development including clinical trial issues, advisory committee meetings, orphan designation, 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.
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.
• Bronchiectasis Physician/Patient Conference, Ask the Experts: Industry Q & A, May 19, 2017
see more blog entries
• FDA and Public Interest Groups Seek to Put Menu Labeling Litigation on Hold . . . For Now,
September 18, 2017
• FDA Announces Forthcoming Menu Labeling Guidance; New York City Suspends Menu Labeling Enforcement for Many Food Establishments,
August 29, 2017
• Restaurants and Convenience Stores Take NYC to Court Over Menu Labeling Requirements,
July 19, 2017
• FDA Grants 30-Day Extension for Comments to Menu Labeling Rule,
June 29, 2017
• FDA Sued Over its Delay of the Menu Labeling Compliance Date and Reconsideration of the Regulations,
June 14, 2017