FDA Warns Lymol To Assess Talc Lead Risk Per ICH Q3D; Puts Others On Notice
A warning letter to firm with legacy talc drug product puts pharmaceutical industry on notice: the US FDA expects applicants to meet requirements agency imposes post-approval for matters like elemental impurities compliance.
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ICH Q3D went into effect in June 2016 for new drugs, but so far doesn't seem to have completely resolved worries about the presence of elemental impurities in drug products.
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