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FDA and ICH seek comment on new exposure levels for cadmium in drug products.
FDA has issued a call for comments on a proposed change to the International Council for Harmonization (ICH) Q3D Elemental Impurities guidance document that corrects a calculation error in the permissible daily exposure (PDE) for cadmium by the inhalation route of exposure.
The ICH Q3D Expert Working Group issued in May 2018 a revised calculation in the document Q3D(R1). The updated PDE of 3 micrograms (μg)/day is based on a modifying factor approach that is consistent with the oral and parenteral PDE calculations.
FDA issued a draft guidance document on July 13, 2018, inviting comments on the proposed changes as part of global regulatory policy harmonization efforts. Comments are due on August 13, 2018.
ICH Q3D Elemental Impuritiesis a quality guideline for the control of metal impurities in drug substances and drug products. The guideline establishes PDEs for 24 elemental impurities for drug products administered by the oral, parenteral, and inhalation routes and offers guidance on how to develop an acceptable level for elemental impurities for drug products administered by other routes of administration.
Source: Federal Register