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Blog: Blog2


Why Your K-Clinic Launch Could Trigger an FDA "Drug Claim" — MoCRA Strategies for 2026
Exosomes, PDRN, and post-procedure care. These are the hottest keywords in the global beauty market today. As K-Beauty shifts its focus from "Glass Skin" to "Recovery and Regeneration," the so-called K-Clinic category is rapidly emerging. This is more than just a trend; consumers now expect professional, clinic-level results directly from their skincare products. However, the moment these expectations are translated into marketing copy, a significant risk arises in the U.S.
Provision Consulting Group
6 days ago3 min read


FDA’s New Guidance on Mandatory Cosmetic Recalls: What Brands Need to Know
How has the FDA cosmetic recall system evolved since MoCRA? In the past, even when issues arose with cosmetics sold in the U.S., they were primarily managed through voluntary recalls by companies. However, with the enactment of MoCRA (Modernization of Cosmetics Regulation Act) in late 2022, the FDA’s legal authority to intervene in the cosmetics sector has become significantly clearer. Recently, the FDA released a Draft Guidance on Mandatory Cosmetics Recalls, outlining the
Provision Consulting Group
Dec 19, 20253 min read


Your Health Data is the New Prescription: Why the FDA is Looking Beyond Trials to 'Real-World' Information
The way we live today is intrinsically tied to data. From the prescriptions we receive at the hospital and the glucose meters we use at home to the ECG features on our smartwatches and the records in our health apps—we are constantly generating a stream of "real-world data." Crucially, this data is now moving beyond simple record-keeping. Recent news indicates that this real-world data can serve as compelling evidence to support new product approvals (or regulatory reviews).
Provision Consulting Group
Dec 15, 20253 min read
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