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Wednesday, January 3, 2024International

Adverse events, registration platform: FDA advances for MoCRA

Effets indésirables, plateforme d'enregistrements : les avancées de la FDA pour le MoCRA

Now officially in force, the Modernization of Cosmetics Regulation Act (MoCRA) continues its gradual implementation. The FDA has made progress on two fronts: the reporting of adverse events mandatory as of December 29, 2023, and the opening of the registration platform for establishments and products, to be completed by July 1, 2024.

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Adverse events

On December 14, 2023, the FDA updated its instructions for reporting serious adverse events due to cosmetic products.
Firstly, it reminds us that the Responsible Person must report them within 15 business days, enclosing a copy of the label or sales packaging, as well as any medical or other information if available.

A serious adverse event is defined by the FDA according to two criteria.
1. Its consequences:
• Death
• A life-threatening experience
• An inpatient hospitalization
• A persistent or significant disability or incapacity
• A congenital anomaly or birth defect
• An infection
• Significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual
2. The means used to treat it:
• A necessary medical or surgical intervention based on reasonable medical judgment.

The FDA had already recommended the use of MedWatch Form 3500A to Responsible Persons. It has now updated its instructions for completing it.

The registration platform

Another FDA press release on December 18, 2023 to announce the opening of Cosmetics Direct, the electronic platform dedicated to …

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