\t\tSubmit Comments by 03\/23\/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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-2275<\/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\n The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \u201cM4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality.\u201d The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to establish a globally harmonized framework to organizing and presenting quality data included in registration applications for medicinal products for human use. The draft guidance updates the quality section of the common technical document (CTD) to further improve registration and life cycle management efficiency, facilitate digitalization and knowledge management, and support provisions for emerging technologies.<\/p>\n Content current as of:<\/p>\n 01\/21\/2026\n<\/p>\n \t\t Regulated Product(s)<\/p>\n \t\t\t Topic(s)<\/p>\n","protected":false},"excerpt":{"rendered":"Submit Comments by 03\/23\/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-256474","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\/256474","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=256474"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/256474\/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=256474"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=256474"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=256474"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\n\t\t FDA-2025-D-2275<\/a>
\n\t \t \t\t Issued by:
\n\t\t <\/p>\n