Attorneys | Steven A. Johnson, Esq..
OF COUNSEL, BENJAMIN L. ENGLAND & ASSOCIATES, LLC
PRINCIPAL, FDAIMPORTS.COM, LLC
Contact Mr. Johnson
Telephone: (949) 224-3879
Facsimile: (949) 242-2822
Mr. Johnson’s practice focuses on FDA compliance strategies and development for Biotech, Medical Device and Pharmaceutical companies. With over 18 years experience, first at the U.S. FDA and subsequently in the Pharmaceutical, Biotechnology and Medical Device Industry, Mr. Johnson brings a seasoned and well-rounded perspective to the firm and it’s clients.
Mr. Johnson began his career in the regulated Food and Drug Industry as an Associate Chief Counsel for Enforcement at the FDA where he was the recipient of the Chief Counsels Special Recognition award for his work as one of the first specially assigned FDA Counsel to the Office of Criminal Investigations (OCI) where he prosecuted enforcement cases throughout the United States as a Special Assistant United States Attorney. Mr. Johnson has previously served as an Assistant General Counsel and in an executive capacity at a major biotech firm for ten years where he successfully negotiated with the Food and Drug Administration numerous intra-agency appeals on NDA/PMA/510k/BLA issues.
Mr. Johnson routinely advises companies on FDA compliance matters including television/radio broadcast and print product marketing/advertising campaigns. He has resolved numerous company cGMP manufacturing, GCP clinical development issues with FDA and developed and implemented corporate wide Compliance Policies and Guidelines. Mr. Johnson is a well-recognized FDA law expert and has lectured on various regulatory and compliance topics on behalf of the Food and Drug Law Institute (FDLI) where he also serves on the Drug/Biologics Committee.
Mr. Johnson advises companies on areas such as:
• Biotech and Medical Device compliance
• Drug/Pharmaceutical compliance, including clinical trials and policy
• Approval and Post Approval Process
• 510k and 513g submissions and process
• Development and implementation of corporate Compliance Policies
• TV, radio, broadcast and print assessments for compliance
• Internet/advertising marketing compliance
• Resolving FDA warning letters and Notice of Violation letters
• cGMP and GCP issues
• Compliance Training
Mr. Johnson received his Juris Doctor degree from Suffolk University School of Law and a Bachelor of Arts in Political Science from Boston College.
State Bar of Massachusetts