Adverse Events Reporting and Recalls under MoCRA: A Blueprint for Designing Your Safety Plan

March 20, 2024 2:00pm

Beth P. Weinman
Ropes & Gray LLP

Laurie A. Henry
Shook, Hardy & Bacon LLP

Nicole Lehr
VP, Associate General Counsel and Ethics Officer
L'Oréal USA

  • Examining FDA’s recall and oversight authority with cosmetics and personal care products under MoCRA
  • Identifying events which would trigger a mandatory recall under MoCRA
  • Developing best practices to design and implement an FDA-mandated MoCRA recall
  • Examining circumstances in which a voluntary recall is warranted
  • What is the nature of the recall?
  • What corrective actions should be taken?
  • Implementing Adverse Event reporting protocols in compliance with MoCRA?
  • When and what AER instances are manufacturers now required to report?
  • Invoking crisis management protocols