Navigating OTC Post-Market Challenges

Navigating Adverse Events, Product Recalls and GMPs Protocols

January 24, 2024 10:45am

Todd Halpern
Assistant General Counsel
Haleon

Diane McEnroe
Partner
Sidley Austin LLP

  • Analyzing best practices for handling product recalls and adverse events
  • Lessons learned from recent OTC drug recalls
    • Updating cGMP protocols in your compliance program based on the latest FDA/industry recall activity
  • Addressing the rise in product and packaging contaminants being identified by third-party labs: when should you initiate a recall and when should you not?
  • Assessing how GMPs should be modified in response to FDA’s recent guidance on nitrosamines