\t\tSubmit Comments by 01\/30\/2026<\/p>\n
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.<\/p>\n
\n\t\t\t \tIf unable to submit comments online, please mail written comments to: <\/p>\n
\n\t\t\t\t Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852 <\/p>\n
All written comments should be identified with this document’s docket number: FDA-2025-D-4678<\/a><\/p>\n \t \t\t\t \tDocket Number: Guidance Issuing Office<\/p>\n Center for Drug Evaluation and Research<\/p>\n Center for Biologics Evaluation and Research<\/p>\n The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \u201cQ3E Guideline for Extractables and Leachables\u201d and a draft supporting document entitled \u201cSupporting Documentation: Class 3 Leachable Monographs.\u201d The draft guidance and supporting document were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance presents a holistic framework and process for the assessment and control of extractables and leachables (E&L) for pharmaceutical products. The draft guidance builds upon ICH impurity guidances on new drug substances (ICH Q3A) and new drug products (ICH Q3B), residual solvents (ICH Q3C), and elemental impurities (ICH Q3D), as well as DNA reactive (mutagenic) impurities (ICH M7). In addition to outlining E&L safety assessment principles, the draft guidance includes draft supporting documentation of Class 3 leachable monographs. The draft guidance is intended to provide approaches to risk-based assessment and control of E&L to ensure patient safety and pharmaceutical product quality.<\/p>\n Content current as of:<\/p>\n 12\/01\/2025\n<\/p>\n \t\t Regulated Product(s)<\/p>\n \t\t\t Topic(s)<\/p>\n","protected":false},"excerpt":{"rendered":"Submit Comments by 01\/30\/2026 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)),…\n","protected":false},"author":2,"featured_media":170923,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[103,61,60,371],"class_list":{"0":"post-170922","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-health","9":"tag-ie","10":"tag-ireland","11":"tag-medication"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/170922","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/comments?post=170922"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/170922\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/170923"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=170922"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=170922"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=170922"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\n\t\t FDA-2025-D-4678<\/a>
\n\t \t \t\t Issued by:
\n\t\t <\/p>\n