US FDA clarifies reporting of serious adverse events for cosmetics
The US Food and Drug Administration (FDA) has issued instructions for reporting serious adverse events under the Modernization of Cosmetics Regulation Act (MoCRA). From 29 December, the statute compels industry to notify the agency about any case linked to...
US FDA rolls out cosmetics listings online platform
The US Food and Drug Administration (FDA) has launched an online system for industry to provide personal care product listings required by the Modernization of Cosmetics Regulation Act (MoCRA). Available on 18 December, the Cosmetics Direct portal was developed...
Updated MoCRA guidance for industry
The FDA finalised draft guidance released in August on registration and listing requirements for cosmetic facilities and products. The guidance includes a new draft appendix meant to answer queries about the entities and items covered under MoCRA. For instance, it...