Cosmetic Safety Substantiation
MoCRA, effective December 2023, requires safety substantiation. It amends the FD&C Act. MoCRA mandates maintaining safety records, facility registration, product ingredient registration, and reporting serious adverse events. This seminar, with insights from experts, will overview cosmetic safety assessment.
FDA Issues Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products
Today, the U.S. FDA has provided an update on its ongoing activities related to serious adverse event reporting mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which are enforceable starting December 29, 2023. A responsible person is...
MoCRA: Facility Registration and Product Listing for Cosmetics
The Clock is Ticking: Are you Ready for Facility Registration and Product Listing under MoCRA? An EAS Complimentary Webinar Presented by John and Catherine Bailey, EAS Independent Consultants and Victoria Pankovich, Manager of Regulatory Services The new requirements...
MoCRA Preparations Should be in Progress
As the cosmetic facility registration and product listing requirement date approaches (29 December 2023), companies needing to register their facility, or list cosmetic products should be gathering the information required to submit to FDA. For facilities that need to...