William Vodra specializes in crisis management and regulatory issues involving the safety, effectiveness, quality, and marketing of medical products, including pharmaceuticals, biologicals, medical devices, and combinations products. He leads teams defending embattled products and represents companies in Food and Drug Administration (FDA) enforcement proceedings, white-collar criminal investigations, and civil litigation. He regularly counsels clients on approval strategies, product life cycle management, promotional practices, safety monitoring and reporting, and good manufacturing practice and quality systems. His work also includes dietary supplements, foods, and cosmetics. He is a frequent author and lecturer on FDA regulatory issues.
Prior to joining Arnold & Porter LLP, Mr. Vodra served as the Associate Chief Counsel for Drugs for FDA, and as Assistant Chief Counsel for DEA. He drafted many agency regulations still in use, including those implementing the Controlled Substances Act and FDA's rules for Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, bioequivalency and the Orange Book.
The Best Lawyers in America 2007-2012 for FDA Law
The International Who's Who of Life Sciences Lawyers 2010
Chambers USA: America's Leading Lawyers for Business 2010 for Healthcare: Pharmaceutical/Medical Products Regulatory
Washingtonian's "Top Lawyers" 2009 for FDA
PLC Which lawyer? Yearbook 2009: Recommended for Life Sciences: Regulatory
Food and Drug Law Institute Distinguished Service and Leadership Award (2006)
Legal Times' "Leading Lawyer in Food and Drug Law" (2005)
Burton Award for Legal Achievement (2005)
Member, Membership Committee, Food and Drug Law Institute
Trustee, Civil War Preservation Trust