Adverse Events Reporting and Recalls under MoCRA: A Blueprint for Designing Your Safety Plan
Beth P. Weinman
Partner
Ropes & Gray LLP
Laurie A. Henry
Partner
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