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China has its own candidate, IBI3032, in early-stage trials in the United States, while other Chinese drugs such as HDM1002 and ASC30 have shown weight-loss results in early studies

For life-science organizations managing the operational side of this compliance question, the challenge increasingly resembles a data and systems problem as much as a clinical one: enrollment goals must be tracked, disaggregated by race, ethnicity, sex, and age, against real-time site-level recruitment data, and reconciled with disease-prevalence benchmarks that sponsors must be prepared to justify to FDA

(10) Other studies have backed up these findings

Their conclusion: the FDA considers a products classification based on its intended use , not its disclaimers