Tag: FDA guidance adverse event reporting
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Serious Adverse Event Reporting for Cosmetics: US FDA MoCRA Compliance Explained
The Modernization of Cosmetics Regulation Act (MoCRA) has significantly strengthened post-market safety oversight for cosmetic products in the United States. One of the most critical obligations introduced under MoCRA is mandatory serious adverse event reporting to the US FDA. Cosmetic companies are now legally required to report serious adverse events associated with their products within…