FDA Issues Draft ICH Revision on Elemental Impurities

July 18, 2018

The FDA released guidance on elemental impurities drafted by the International Council for Harmonisation that would revise the permitted daily exposure for cadmium.

The draft, Q3D(R1) Elemental Impurities, proposes a new inhalation value of 3.4 micrograms/day, doubling the previous value of 1.7. The higher value corrects a previous calculation error in the PDE for cadmium by the inhalation route of exposure.

The agency called for comments by Aug. 13 on the draft document.

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