{"id":178,"date":"2019-10-31T10:52:20","date_gmt":"2019-10-31T14:52:20","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=178"},"modified":"2019-10-31T10:52:20","modified_gmt":"2019-10-31T14:52:20","slug":"in-a-regulatory-one-two-fda-modifies-terms-of-oversight-concerning-homeopathic-drugs","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2019\/10\/31\/in-a-regulatory-one-two-fda-modifies-terms-of-oversight-concerning-homeopathic-drugs\/","title":{"rendered":"In a Regulatory &#8220;One-Two,&#8221; FDA Modifies Terms of Oversight Concerning Homeopathic Drugs"},"content":{"rendered":"<p>Late last week, the FDA\u2014in denying a citizen petition and issuing two\u00a0<a title=\"Compliance Policy Guide Sec. 400.400 Conditions Under Which Homeopathic Drugs May Be Marketed; Withdrawal of Guidance \" href=\"https:\/\/www.govinfo.gov\/content\/pkg\/FR-2019-10-25\/pdf\/2019-23334.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Federal Register notices<\/a>\u2014modified published guidance on the manufacture and distribution of homeopathic drugs and declined to convert a current policy guide (CPG) provision into an official regulation. Importantly, the FDA cautioned industry participants and consumers alike that its CPG withdrawal \u201cdoes not represent a change in the legal obligations that apply to homeopathic drugs\u201d; rather, the CPG\u2014issued in 1988\u2014merely no longer reflects the \u201ccurrent thinking\u201d of the FDA, as it is inconsistent with the agency\u2019s \u201crisk-based approach to enforcement generally.\u201d<\/p>\n<p><a href=\"https:\/\/www.duanemorris.com\/alerts\/regulatory_one_two_fda_modifies_terms_oversight_concerning_homeopathic_drugs_1019.html\">View the full <em>Alert<\/em> on the Duane Morris LLP website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Late last week, the FDA\u2014in denying a citizen petition and issuing two\u00a0Federal Register notices\u2014modified published guidance on the manufacture and distribution of homeopathic drugs and declined to convert a current policy guide (CPG) provision into an official regulation. Importantly, the FDA cautioned industry participants and consumers alike that its CPG withdrawal \u201cdoes not represent a &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2019\/10\/31\/in-a-regulatory-one-two-fda-modifies-terms-of-oversight-concerning-homeopathic-drugs\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;In a Regulatory &#8220;One-Two,&#8221; FDA Modifies Terms of Oversight Concerning Homeopathic Drugs&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[29,414,413,388,298,119],"ppma_author":[521],"class_list":["post-178","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-fda","tag-homeopathic","tag-homeopathy","tag-justin-stern","tag-patrick-gallagher","tag-rick-ball"],"authors":[{"term_id":521,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/178","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=178"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/178\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=178"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=178"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=178"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=178"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}