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
DIA 2016 Annual Meeting, June 26-30, 2016
AJV 6/27 Speech: "Priority Review Vouchers: Past Experiences, Legislative Reform, and Tips for Sponsors"
AJV 6/28 Speech: “Life After Amarin and Pacira: Understanding Off-Label Promotion in 2016”; JEV 6/29 Speech: "The Utility of Natural History Studies in Drug Development and Approval"; JEV 6/29 Moderator: "FDA Rare Disease Town Hall"
Regulatory Operations and Submissions, April 27-28, 2016
AJV 4/27 Speech: “Dossier Considerations for Submissions Eligible Expedited Review Programs”; and 4/28 Speech: “Successful Orphan Drug Applications”
FDLI, Introduction to Drug Law and Regulation, April 12-13, 2016
4/12 Speech: The New Drug Approval Process: NDA Submission adn Review
FDLI, Introduction to Medical Device Law: Registration and Listing, June 16, 2015
DIA 2015 Annual Meeting: The Breakthrough Therapy Designation: An Analysis of FDA’s Precedents to Determine Eligibility Criteria and Their Value, June 17, 2015
see more blog entries
FDA Updates Breakthrough Therapy Program: Meet the Preliminary Breakthrough Therapy Designation Request,
March 22, 2016
GAO Issues Report on Pediatric Voucher Program, Findings Inconclusive,
March 3, 2016
New Life for the Pediatric Priority Review Voucher Program,
December 29, 2015
Nearing its Sunset, Pediatric Voucher Program Gains Momentum,
December 13, 2015
Priority Review Voucher Updates: Valuation, Eligibility, Reauthorization,
August 30, 2015