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This is an independent nonprofit organization that works with the FDA to set quality standards for medicines

The drug is not recommended for anyone who is pregnant or who may become pregnant

NHS access then depends on a NICE technology appraisal, which assesses whether the health benefits justify the cost to the NHS

3 Histopathology of a labial macule reveals prominent basilar hyperpigmentation accentuated at the tips of the rete ridges without atypia or nevoid formation