FDA Attorney

How FDA Counsels Can Help You

Provide Guidance and review of Company drug/device promotional materials; provide counseling and advocacy on FDA medical device matters, including device clearance (510(k), PMA, etc.), and enforcement and compliance issues.

Please use the form below to tell us about your legal needs.

In-House
FDA Counsel

As FDA counsel for many F500 companies, Mr. Johnson's experience is second to none. He negotiated a guilty plea for the largest fine of a generic drug manufacturer for cGMP violations. He also assisted in overturning negative FDA advisory panels eventually securing FDA NDA approval. He knows how to secure FDA reversals of combination drug/device designation. Mr. Johnson also negotiated waivers of new drug exclusivity with competitor companies resulting in a $10m payment.

Mr. Johnson has substantial experience advising and representing firms as an in-house counsel with FDA work and related matters. He looks forward to supporting you with your legal matters.

Allergan

Why Work With FDA Counsels?

Mr. Johnson is the hired gun you need on your team to navigate complex FDA issues.

Services

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

Events

See the events that Mr. Johnson is and has been involved in.

Balance

Advocacy

Depend on our advocacy team to work with policymakers.

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.

What Our Clients says

5/5

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 Caviar

CEO, SpineOvations Inc.

5/5

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 Albright

Aesthetic Industry Strategic Consultant

5/5

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, MD

Executive VP and Chief Medical Officer, Zogenix, Inc.

5/5

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 Caviar

CEO, SpineOvations Inc.

5/5

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 Gammatoni

Former Merck Executive and Zogenix VP of Medical Affairs

5/5

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 Caviar

CEO, SpineOvations Inc.

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