Alexander J. Varond
J.D., George Washington University Law School
B.S., Biomedical Engineering and Management Science (double major), University of California, San Diego
District of Columbia
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Alexander J. Varond works on medical device and drug development, advertising and promotion, and enforcement issues. He counsels clients on development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution, and patent and exclusivity issues. Mr. Varond also supports ongoing litigation efforts and performs due diligence for corporate transactions.
Mr. Varond's professional experience includes roles as project engineer, operations manager, and deputy management representative to FDA in the medical device industry. He also served as a law clerk at the U.S. International Trade Commission's Office of Unfair Import Investigations, and as an Intellectual Property Law Clerk at NuVasive, Inc.
In law school, Mr. Varond was the national runner-up, placing second in the nation, in the 2010-2011 National Giles S. Rich Intellectual Property Moot Court Competition. He was also named Best Overall Competitor and won the award for Best Brief for his efforts in The George Washington Law School's intellectual property moot court competition in 2011. Mr. Varond co-taught legal writing and research as a Dean's Fellow and Writing Fellow, and was a member of the Alternative Dispute Resolution Board.
Prescription Drugs and Biologics
• Advises on matters involving product development, regulatory compliance, and submission strategies.
• Drafts and aids in requests for formal dispute resolution with FDA.
• Counsels clients on Hatch-Waxman patent and exclusivity matters.
• Assists companies with development of REMS, including shared REMS.
• Drafts citizen petitions requesting specific FDA actions.
• Counsels on compliance with cGMP and other manufacturing requirements.
• Provides guidance on compliance, including labeling, advertising and promotion, QSR, MDR, establishment registration, product listing, and device modifications.
• Drafts and reviews 510(k)s, PMAs, de novo petitions, and related submissions.
• Conducts due diligence for SEC filings and corporate transactions.
• Provides regulatory assistance related to investigations of criminal, civil and administrative charges, such as charges under the False Claims Act.
• Assists pharmaceutical and device companies with regulatory compliance, FDA inspections, and warning letters.
Articles / Publications
• Commercialisation of Healthcare Global Guide,
January 19, 2016
• Bringing Your Pharmaceutical Drug to Market,
April 1, 2015
• Thomson Reuters Book: Commercialisation of Health Care,
November 4, 2013
• Trends in Personalized Medicine,
see more speaking engagements
• Webinar: Decoding FDA’s Special Protocol Assessment (SPA) Program and Revised Guidance, October 26, 2016
• DIA 2016 Annual Meeting, Life After Amarin and Pacira: Understanding Off-Label Promotion, June 28, 2016
• DIA 2016 Annual Meeting, Priority Review Vouchers: Past Experiences, Legislative Reform, and Tips for Sponsors, June 27, 2016
• Regulatory Operations and Submissions, AJV 4/27 Speech: “Dossier Considerations for Submissions Eligible Expedited Review Programs”; and 4/28 Speech: “Successful Orphan Drug Applications”, April 27-28, 2016
• FDLI, Introduction to Drug Law and Regulation, 4/12 Speech: The New Drug Approval Process: NDA Submission adn Review, April 12-13, 2016
see more blog entries
• Pediatric Priority Review Vouchers Saved in the Eleventh Hour,
October 4, 2016
• Senate Votes to Extend Pediatric Voucher Program and Expand Eligibility,
September 26, 2016
• The Pediatric Voucher Program and Its Impending Renewal Deadline,
September 22, 2016
• FDA Revises Guidance on Special Protocol Assessments, Attempts to Reduce Uncertainty,
May 9, 2016
• FDA Updates Breakthrough Therapy Program: Meet the Preliminary Breakthrough Therapy Designation Request,
March 22, 2016