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.
• 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
Thomson Reuters Book: Commercialisation of Health Care,
November 4, 2013
Trends in Personalized Medicine,
DIA 2015 Annual Meeting, June 14-18, 2015
, July 16, 2014
Introduction to Orphan Drug Development and Exclusivity
see more blog entries
FDA Revises Formal Meetings Guidance for PDUFA Products,
April 6, 2015
The Advancing Hope Act of 2015 – A First Shot at Reauthorizing the Rare Pediatric Disease Priority Review Voucher Program,
March 26, 2015
One, Two, Three . . . and They’re Out! FDA Issues Third Rare Pediatric Disease Priority Review Voucher, Triggering One-Year Sunset Clause,
March 23, 2015
FDA Formalizes Procedures for Expediting Review of Certain Applications with Breakthrough Therapy Designation,
March 13, 2015
FDA Clarifies Its Rare Pediatric Disease Priority Review Voucher Program,
November 20, 2014