Tag: What is an adverse event according to the FDA?
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Cosmetic Adverse Events: US FDA Requirements, MoCRA Rules, and Compliance Obligations
Cosmetic safety does not end once a product reaches the market. Under United States law, cosmetic companies are legally responsible for monitoring, documenting, and reporting cosmetic adverse events. With the enactment of the Modernization of Cosmetics Regulation Act (MoCRA), adverse event reporting has become a mandatory and enforceable requirement under the authority of the US…
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Form FDA 3500A and Cosmetic Adverse Event Reporting: Regulatory Reporting Under MoCRA
The Modernization of Cosmetics Regulation Act (MoCRA) fundamentally changed how cosmetic safety issues must be reported in the United States. Cosmetic companies are now legally required to report serious adverse events associated with their products to the US FDA within defined timelines. One of the primary tools used to fulfill this obligation is Form FDA…