FDA LEGAL COUNSEL EXPERTS
We Help Solve FDA
Successfully Navigate The Maze Of FDA Legal
And Regulatory Requirements
Mr. Johnson has represented Pharma companies before hearings at the Federal Trade Commission (FTC), the Food and Drug Administration (FDA) and defended OTC drug client’s advertising from competitor’s challenges before the
National Advertising Division (NAD) of the Better Business Bureau. He has also successfully defended companies in litigation before the US District Court.
Steven A. Johnson
Steven A. Johnson is the principal at FDACOUNSELS.COM a full service legal, regulatory and compliance consulting firm located in Southern California. Steve has led the Global Legal and Compliance functions at pharmaceutical and device firms advising specifically on FDA legal and regulatory matters. Additionally, Steve was with FDA where he served as an Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel trying OCI criminal and civil cases against the Food, Drug and Device regulated industry around the United States. He was a recipient of the Office of Chief Counsel’s Special Recognition Award and received his BA from Boston College and his JD from Suffolk University School of Law. He is a regular guest lecturer at industry groups such as the Food & Drug Law Institute and the Pharmaceutical Compliance Forum.
In-House FDA Counsel
See How We Can Help
Many legal challenges relate to where you are in the company's life cycle.
Mr. Steven Johnson has been addressing FDA legal issues for over 30+ years.
See the events that Mr. Johnson is and has been involved in.
Our Focus Areas
Secured FDA reversal of agency’s initial denial of 3-year exclusivity under Hatch-Waxman.
Unique Topical Drug
Spearheaded strategy to fight FDA’s proposed withdrawal of client’s.
Developed overall strategy leading to filing and approval of New Drug Application (NDA)
FDA counsel to major compounding pharmacy; led strategy to establish separate subsidiary to obtain formal FDA
Penned waiver requests under Pediatric Research Equity Act (PREA) as applicable to NDAs being filed by clients.
Coordinated all aspects of recall of pharmaceutical, including securing health assessment, drafting recall letters and press releases.
Transactions FDA Enforcement
And Crisis Management
No matter when or why an FDA-related issue confronts you or what it relates to, you need
experienced counsel. More information on the services I provide can be found below.
FDA Legal Services For The Life Of A Life Sciences Company
Product and Issue Specific Services
Past Presentations and Articles
Special Closed-Door Session- Invitation Only Chief Compliance Officer Round Table Hosted by Pharmaceutical Compliance Forum Tuesday, November 2, 2021 1:00-4:00pm Please Note:
Updates for 2021 FDLI remains committed to providing high-quality educational programs while keeping our members and event attendees safe during the current