
FDA Invites Comment on New Exposure Limits for Cadmium
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FDA issued a draft guidance document on July 13, 2018, inviting comments on the proposed changes as part of global regulatory policy harmonization efforts.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.
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