Walking a Tightrope: How to Manage MoCRA’s Adverse Event Requirements While Protecting Yourself in Future Litigation

Join partners Rebecca Dandeker and Rachel Raphael with Marcha Chaudry, Founder of the Equity & Wellness Collaborative, for a discussion on the ins and outs of adverse event recordkeeping and serious adverse event reporting under the Modernization of Cosmetics Regulation Act (MoCRA), from practical advice on how to navigate compliance obligations to critical considerations for companies seeking to protect themselves in the event of a lawsuit.

Topics will include:

• A brief overview of MoCRA, with a focus on the US Food and Drug Administration’s (FDA’s) expectations for recordkeeping and reporting of adverse events involving cosmetic products
• A practical “how-to” discussion regarding compliance, including common pitfalls and misconceptions
• Key litigation considerations implicated by MoCRA’s requirements, including best practices for documenting adverse events involving third parties, communicating internally, preparing for FDA records inspections, and protecting documents and communications