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In an embryofetal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075, and 0.15 mg/kg twice weekly (0.5-, 3-, and 8-fold the MRHD) were administered throughout organogenesis, from Gestation Day 16 to 50

The CREATES Act and REMS Abuse The CREATES Act (Creating and Restoring Equal Access to Equivalent Samples), passed in 2019, addressed a specific abuse: brand manufacturers withholding drug samples from generic manufacturers who need them to conduct bioequivalence studies [55]

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