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Provided by James R Johnson
JIM JOHNSON guides life sciences companies through complex U.S. Food and Drug Administration (FDA) compliance and enforcement matters. Positioned at the forefront of FDA compliance and regulatory issues critical to the business of his clients, Jim excels at knowing what’s ahead. He counsels life sciences companies on a range of FDA matters, including inspections, current good manufacturing practice (GMP) requirements, supply-chain and product-quality issues, product approvals, pharmacovigilance obligations, and enforcement actions. He helps clients around the world identify compliance risks early, prevent problems from happening, efficiently resolve issues with minimal corporate pain, and improve agency relationships. Jim knows the FDA well, having served as Associate Chief Counsel for Enforcement in the FDA’s Office of the Chief Counsel. At FDA Jim handled GMP enforcement and provided legal counsel on a range of inspectional and compliance issues to agency components.
Provided by Chambers
James Johnson advises clients on complex FDA regulatory matters, including data privacy issues and inspections. He is known for his ability to advise on good manufacturing practice.
Provided by Chambers
Jim is a strategic thinker with technical knowledge that enables him to give timely, robust advice. He is a sophisticated lawyer who is well-versed in pharmaceutical commercial issues.
Jim is extremely helpful as a sounding board and adviser.
Jim is excellent and gives good practical advice. He has deep knowledge of the FDA, their staff and the leadership. He is a broad thinker who is able to provide good landscape awareness.
Jim is very good on the inspection side of regulatory regime and how to navigate through difficult inspections.
Jim is a strategic thinker with technical knowledge that enables him to give timely, robust advice. He is a sophisticated lawyer who is well-versed in pharmaceutical commercial issues.
Jim is extremely helpful as a sounding board and adviser.
Jim is excellent and gives good practical advice. He has deep knowledge of the FDA, their staff and the leadership. He is a broad thinker who is able to provide good landscape awareness.
Jim is very good on the inspection side of regulatory regime and how to navigate through difficult inspections.