Steve Silverman, The Silverman Group

Steve Silverman helps lawyers handling FDA matters explain regulatory requirements to judges, juries, and opposing counsel, drawing from his extensive FDA and private-sector career. At FDA, Steve helped lead the medical device and human drug centers. After leaving FDA, Steve joined McKinsey & Co., where he counseled medical-product clients on regulatory and compliance matters. He now runs The Silverman Group, guiding clients on medical product regulatory, strategy, and policy issues.

Steve’s legal experience adds to this work. Steve served federal agencies including the US Department of Justice, where he was a trial counsel. These experiences allow Steve to work efficiently with counsel to develop credible analysis and compelling testimony.

Services:

• Expert deposition and trial testimony
• Expert reports
• Discovery and case-strategy development
• Issue investigation
• Regulatory review and analysis

Expertise:

• FDA postmarket medical product regulation
• Medical product approval and marketing requirements
• Medical product good manufacturing practice and labeling
• Medical product labeling, advertising, and promotion
• Medical product postmarket vigilance and reporting
• Medical product recalls and field actions
• FDA regulatory practice, strategy, and engagement

BA, JD