James R Johnson

Practice Areas

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 practices (GMP) requirements, data integrity responsibilities, product quality and approval issues, 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, particularly the FDA's Office of Regulatory Affairs (ORA) and Center for Drug Evaluation and Research’s (CDER) Office of Compliance.