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

Overview:
 
How life sciences organizations communicate with the U.S. FDA can influence regulatory outcomes, patient safety, and brand reputation. Strategic, well-prepared engagement not only helps prevent product-safety issues from escalating but also strengthens trust and credibility with the agency.
 
Today, the stakes are higher than ever. Class I recalls are trending well above their five‑year average, and the Department of Health and Human Services (HHS) is launching a major reorganization of the FDA, including structural shifts and intensified scrutiny. In this shifting landscape, the way you engage with the FDA is not just important, it’s critical.
 
Join us on December 10 for a focused 30-minute webinar, where our legal partners and regulatory specialists will share insightful, expert-led guidance on navigating FDA interactions. Discover, how leading organizations engage with clarity, confidence, and a strategic focus on product safety during these uncertain times. 
 
Key takeaways:
  • Regulatory Clarity: Proven approaches to craft messages that meet FDA expectations.
  • Avoiding Pitfalls: Common communication missteps, and how to prevent them.
  • Building Trust: Strategies to strengthen relationships and credibility with the FDA.
  • Proactive Engagement: How structured dialogue can reduce risk and protect product safety.
  • Futureproofing: Embedding best practices for sustainable compliance and organizational readiness.

 

This session will equip leaders to:

  • Communicate with confidence in high-stakes interactions with FDA regulators.
  • Strengthen organizational credibility amid increasing regulatory scrutiny and expectations.
  • Turn regulatory challenges into strategic opportunities for resilience and long-term success.

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 7,000 of the most sensitive and time critical product recall programs, spanning 150+ countries and 50+ languages.