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Effective FDA Engagement
FDA faces challenges (like new technology) and new review models (like real world evidence) that stretch agency standards and practices. At the same time, imperatives like product safety and efficacy continue.

Against this backdrop, effective regulator engagement is critical. Stakeholders like medical product companies need good engagement to understand both where FDA may be flexible and where it will follow past practice.

This webinar will explore topics including what effective FDA engagement is, what effective engagement will and won’t provide, best engagement practices, and what is the right engagement level. The webinar also will explore how product and regulatory innovation affects engagement scope and practices.

Learning Objectives:
• What effective FDA engagement is, including its benefits and its limits
• Principles of effective FDA engagement, including where to engage, who to engage, and how to engage
• How high-priority strategic and regulatory issues affect FDA engagement

00:57:00

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Speakers

Steve Silverman
Expert Consultant, NDA Partners
Steve’s professional experience includes nearly two decades in federal service, with extensive time in senior FDA roles. At FDA, Steve directed the CDRH Office of Compliance, where he led device-quality initiatives, engaged Congress and the press, and guided the office’s reorganization.