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 Recently, the FDA released a Draft Guidance on Mandatory Cosmetics Recalls, outlining the
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).