FDA LEGAL COUNSEL EXPERTS
We Help Solve FDA
Legal Challenges
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.
Services
In-House FDA Counsel
Mr. Johnson has substantial experience advising and representing firms as an in-house counsel with FDA work and related matters.
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Services
Many legal challenges relate to where you are in the company’s life cycle.
Biography
Mr. Steven Johnson has been addressing FDA legal issues for over 30+ years.
Events
See the events that Mr. Johnson is and has been involved in.
Our Focus Areas
Rx-OTC Switch
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.
Cancer Pain
Developed overall strategy leading to filing and approval of New Drug Application (NDA)
Pharmacy
FDA counsel to major compounding pharmacy; led strategy to establish separate subsidiary to obtain formal FDA
Analgesic Products
Penned waiver requests under Pediatric Research Equity Act (PREA) as applicable to NDAs being filed by clients.
Health Assessment
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 Services
Ad Hoc Services
Life Cycle
Product Services
You may be seeking FDA legal expertise to tackle a challenge relating to a certain type of product.
Click To Product Services
Ad Hoc Services
Some FDA legal issues can arise on an ad hoc basis at any time in a client’s life cycle, particularly those relating to Transactions, or Compliance & Enforcement.
View Hoc Legal Services
Life Cycle
Wherever you may stand in the life cycle of your Life Sciences company — from Corporate Formation/Financing to R&D to Marketed Products.
Learn More About Life Cycle
View All Services
Steve is one of the best regulatory executives and attorneys I have
worked with in the life sciences. He is knowledgeable, dedicated,
and has a deep command of all the nuances of the regulatory process
and how to accomplish business objectives.
Niv Edward CaviarCEO, SpineOvations Inc.
Steve Johnson is absolutely the finest regulatory attorney I’ve worked with in my 20+ years in the pharmaceutical industry. His vast experience, wide reaching knowledge, and his uncanny ability to find solutions is beyond that I’ve seen with any other capable attorneys I’ve worked with. He is always finding the optimal regulatory and ethical result that moves the business forward. Without doubt I will continue to work with Steve and recommend him to all who require such services.
Brad Galer, MDExecutive VP and Chief Medical Officer, Zogenix, Inc.
Besides his extensive legal and compliance knowledge, what separates Steve from previous industry attorney’s I’ve worked with is his willingness to work with you as a true and trusted collaborator, to find the best options in dealing with industry challenges. An example of this is how he helped us in Investigator Initiated Studies contract review and negotiations maximizing protection of our IP and ensuring they were aligned with latest best practices from a compliance perspective.
Dr Arnold GammatoniFormer Merck Executive and Zogenix VP of Medical Affairs
I have worked closely with Steve Johnson for over 20 years. So when he announced that he was setting up his advisory service for legal and regulatory support, I was quick to reach out for his support on a complex project. Steve has extensive knowledge of our space, and if he doesn’t have the answer directly he can enlist the support of numerous SME’s that are among his connections. I highly recommend Steve!
Tom AlbrightAesthetic Industry Strategic Consultant
Product and Issue Specific Services
Clinical Research
ADVERTISING & PROMOTION
Cosmetics
Devices & IVDs
Dietary Supplements & Functional Foods
Food & Additives
Drugs and Therapeutic Biologics
OTC Drugs
Crisis Management
Past Presentations and Articles
Events
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