M7(R2) Addendum: Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes; International Council for Harmonisation; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "M7(R2) Addendum: Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes; International Council for Harmonisation; Draft Guidance for Industry." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance adds monographs for seven new compounds to the M7 Guideline which outlines considerations for assessment and control of DNA reactive (mutagenic) impurities to limit potential carcinogenic risk. The compounds are: Acetaldehyde, dibromoethane, epichlorohydrin, ethyl bromide, formaldehyde, styrene, and vinyl acetate. The addendum is intended to update the M7 Guideline in line with the ICH process for its maintenance and includes other revisions.