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    FDA Adopts, Releases ICH Document on Dose Uniformity

    The US Food and Drug Administration (FDA) has adopted and released a new guidance document intended to clarify the International Conference on Harmonisation's (ICH) Q4B guideline on the use of pharmacopoeial texts. Background ICH is a regional harmonization group composed of the US, EU and Japan, as well as other countries which serve in a voluntary capacity. The aim of the group is to allow the regulatory processes of each to better align with those of the others,...