Interacting with the FDA During a Recall - Watch Now:
Key insight for recall planning and execution

Overview:

Navigating regulatory requirements in the life sciences sector has become increasingly complex as standards evolve and expectations from regulatory bodies intensify.
 
For pharmaceutical and medical device manufacturers, the first interactions with the FDA during a recall can significantly influence the recall's trajectory and your brand’s reputation. In these initial days, every action matters.
 
In-detail:
 
In this 30-minute masterclass, we outline the essential practices and strategies that will enable you to secure a strong initial footing during this pivotal time.
 
Whether you’re experienced with FDA engagement or facing it for the first time, our expert panel – equipped with decades of life sciences and regulatory experience – will walk you through best practices for setting the right tone, responding effectively, and building a foundation for trust and compliance during the initial recall response.
 
Prepare your company for confident, compliant action when it matters most—gain access now to master FDA interactions.
 

During this 30-minute session (and accompanying insights guide), you’ll discover:

  • The current regulatory landscape at the FDA and projected developments in 2025.
  • What companies should anticipate when first interacting with the agency, whether through an initial report or during a potential recall.
  • Key strategies for effective communication and documentation with the FDA in the critical early weeks following a product safety report.
  • Common mistakes companies face when initially engaging with the agency, and tips on how to avoid them.
  • Recommendations on early steps in the reporting or recall process that lay the groundwork for future success.

Chris Harvey

Chris Harvey

Sr. Vice President, 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.

Michael Heyl

Partner, Hogan Lovells
Mike Heyl helps life-science companies navigate myriad regulatory and business matters. He guides clients through U.S. FDA regulations, requirements, and compliance issues. These issues include FDA's Quality System Regulation; adverse event reporting; recall reporting requirements; FDA inspections and enforcement actions.
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 100+ countries and 50+ languages.