As cosmetics manufacturers and suppliers have ‘a responsibility to ensure the safety of their products,’ industry members must understand the critical tenants of cosmetic safety substantiation under MoCRA. In this seminar, Dr. Paula Brock of EAS reviewed...
AHPA Director of Regulatory Affairs Robert Marriott discusses serious adverse event reporting (SAER) requirements, FDA’s upcoming proposed rule on labeling of fragrance allergens, and more to note in the months ahead.
SPL XForms are now an additional option for cosmetic companies for submission along with the Cosmetic Direct portal, FDA Electronic Submission Gateway (ESG), as well as paper Form FDA 5066 and Form FDA 5067.
It’s been a busy week for the US Food & Drug Administration, with the Agency publishing, issuing, launching, and releasing a raft of MoCRA-related updates.
Updated deadlines, the announcement of a newly developed draft submission portal, and the release of several different draft guidance documents are just some of the developments that have occurred this year regarding MoCRA’s implementation of cosmetic...
In the report, GAO examined research on cosmetic ingredient safety and FDA implementation efforts of MoCRA thus far, which concluded with seven recommendations to 'strengthen FDA's efforts to implement its new cosmetic safety oversight responsibilities,...
Manufacturers and suppliers to the cosmetics and personal care product industries can now adjust their strategies for MoCRA compliance following the FDA's recent announcement confirming a six-month extension of the facility registration and product...
Newly issued guidance on the intent to delay enforcement of these key regulatory requirements under MoCRA for six months will allow cosmetics and personal care product companies more time to enact compliance measures.
To glean the most important takeaways from the FDA’s latest recommendations outlined in the draft guidance document published earlier this week, CosmeticsDesign interviewed associate Kelly Bonner of Duane Morris LLP and partner Jessica O’Connell of Covington...
In accordance with MoCRA, the FDA’s draft guidance document outlines recommendations to establish a new electronic submission system to replace the Voluntary Cosmetic Registration Program (VCRP) by the end of this year.
As part of MoCRA regulations, the FDA has until December 2024 to propose a cosmetic GMP standard, which will have significant impact on manufacturers and suppliers to the cosmetics and PBC product industries.
This year’s convention featured over a dozen different scheduled seminars covering a myriad of pressing issues in the regulation of personal care products including PFAS, clean beauty, sunscreens, international issues, and MoCRA legislation, and was the...
The FDA opened a Listening Session for public commentary of the Good Manufacturing Practices section of MoCRA today with an open docket for commentary through July 3, 2023.
Manufacturing and cosmetics companies looking to best adhere to MoCRA regulations should consider digital support to achieve compliance, suggests Specright VP Tom Preston.
As the FDA continues to implement changes to begin enforcing some of MoCRA’s authorities and industry requirements by the end of this year, CosmeticsDesign checks in with Victor Mencarelli, Director of Global Regulatory Affairs at Orveon, to learn more...
From the FDA’s new mandatory recall authority to reporting and record-keeping requirements for serious adverse events, we caught up with attorneys from Perkins Coie on the key aspects of the Modernization of Cosmetics Regulation Act.
