U.S. FDA Engagement Strategies
Essential insight to safeguard patient and product safety

Overview:
 
Engagement with the U.S. FDA is a defining moment in the management of any product incident or recall. The clarity, structure, and timeliness of your communication can influence the level of scrutiny applied, the speed of regulatory close-out, and the confidence of patients and healthcare partners who depend on decisive action.
 
Join us on December 10 for a focused 30-minute webinar led by our product safety specialists and strategic legal partners at The Silverman Group. This session will distil the essential principles of effective FDA engagement – providing organizations with practical, proven frameworks to support stronger outcomes during periods of pressure and uncertainty.
 
Key takeaways:
  • How to craft clear, authoritative communication that aligns with FDA expectations.
  • The missteps that most frequently prolong regulatory dialogue, and how to avoid them.
  • When and how to use different engagement formats to support clarity and control.
  • Ways to demonstrate organizational command and foster regulator confidence.
  • How evolving FDA structures and rising recall activity are shaping the communication landscape.

This session will equip leaders to:

  • Engage the FDA with clarity, discipline, and credibility.
  • Navigate heightened scrutiny with greater control and preparedness.
  • Maintain momentum toward regulatory close-out.
  • Bolster resilience ahead of emerging product-safety challenges.

Overview

Date: December 10, 2025
U.S. Time: 11:00 AM EST
European Time: 4:00 PM GMT / 5:00 PM CET
Duration: 30 minutes

Chris Harvey

Chris Harvey

Senior VP, Client Services, Sedgwick
Chris is recognized as an expert in the recall industry and routinely speaks on best practices at trade shows, conventions, and conferences. Throughout his career, he has managed more than 1,200 recall and in-market remediations, including hundreds for the nation’s largest brands.
Steve Silverman

Steve Silverman

President, The Silverman Group
Steve Silverman is President of The Silverman Group, advising medical companies on regulatory, strategy, and policy issues. As a former FDA senior leader and McKinsey expert, Steve brings decades of experience helping organizations strengthen regulatory relationships, resolve compliance challenges, and shape quality strategies.
 

About Sedgwick Brand Protection

Trusted by the world’s leading brands and most relied on businesses, Sedgwick brand protection is the market-leading provider of best practice product recall and remediation solutions.

With a 30-year track record of successfully protecting businesses, their customers and our environment, we’ve managed more than 8,000 of the most sensitive and time critical product recall programs, spanning 150+ countries and 50+ languages.