Major foreign news outlets, including CNN, are reporting that the US federal government shutdown is finally nearing its end. While an official termination announcement has not yet been made, the normalization of government operations is imminent. Once federal agency operations resume, medical device registration and renewal processes, which had been suspended, will fully restart. This period is historically the time when system delays and errors are most frequent, as companie

Gen Z: The New Core of the Global Beauty Market Gen Z (born 1997–2012) has firmly established itself as a pivotal consumer group in the global beauty market. Global consumer reports from BCG and McKinsey estimate their direct purchasing power at approximately $360 billion. Furthermore, they are recognized as an ‘Influential Consumer’ segment, significantly impacting the purchasing decisions of their peers and families. This generation maintains clear criteria for consumption.

Provision Consulting Group highlights K-Beauty's status and challenges as a speaker at the U.S. ACI Forum  "My daughter has watched K-Pop Demon Hunters five times already. She knows more about the K-Beauty products she sees on social media than I do." This comment from a regulatory expert at ACI’s Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products  in Santa Monica, California, on October 8, drew laughter from the audience. It solidified how deeply t

The FDA recently issued Warning Letters to two overseas medical device manufacturers, citing significant violations of the Quality System Regulation (QSR) . This action is not a mere administrative notification; it sends a powerful message that the FDA is actively stepping up scrutiny of overseas manufacturing operations and their capacity for effective quality system management. Both companies were found to have systemic failures in product testing and validation procedures,

People are now applying serums not just to their faces, but also to their scalps. The growing recognition that ‘the scalp is an extension of the face’ is extending skincare routines up to the top of the head. This trend, known as Skinnification , where the principles of skincare expand to hair and body, is ushering in an era of ‘managing hair and scalp like skin.’ At the heart of this change is K-Haircare, an evolution of K-Beauty that has thrived on ingredients and science.

Amidst the heightened scrutiny under the updated MoCRA FDA regulations, many companies are feeling the pressure. Here's the success story of global enterprise S, which partnered with Provision to establish a clear, strategic response and overcome the complex regulatory hurdle. This wasn't just about procedure; it was about a sincere partnership. The Challenge: A Global Company Confronts Unfamiliar Regulations Since the enforcement of the Modernization of Cosmetics Regulation

The recent failure of the U.S. federal government to reach a budget agreement has led to a government 'shutdown'. While we're used to...

A Look at U.S. Market Regulations Through a Recent FDA Warning Letter “An FDA warning letter? That's only for big corporations, right?”...

Companies looking to enter the U.S. cosmetics market should pay close attention to the latest news from the FDA regarding MoCRA...

As an Amazon seller, you might face the sudden deactivation of a listing or receive a warning email without any notice. Many sellers,...