Zdrowie i gospodarka · 01/07/2016

FDA Releases Draft Guidance on Elemental Impurities in Drug Products

The Food and Drug Administration (FDA) has made available a draft guidance for industry on controlling elemental impurities in human drug products marketed in the US, in line with International Council for Harmonisation (ICH) Q3D guidance and the US Pharmacopeia's (USP) requirement for elemental impurity control.