{"id":3536,"date":"2023-10-10T09:02:00","date_gmt":"2023-10-10T09:02:00","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=3536"},"modified":"2025-11-03T10:17:57","modified_gmt":"2025-11-03T10:17:57","slug":"pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/","title":{"rendered":"Pharma\/Biotech – USA, Europe Regulatory News, Oct 2023 Vol. 1"},"content":{"rendered":"\n<\/span>

\n

USA<\/h2>\n\n\n\n

FDA Draft Guidance Pushes for Development of Stimulant Use Disorder Treatments<\/strong><\/p>\n\n\n\n

With no FDA drug approvals to date for stimulant use disorder, the FDA published draft guidance outlining current recommendations for development programs and trial designs for treatment of moderate-to-severe cocaine use, methamphetamine use and prescription stimulant use disorder.<\/p>\n\n\n\n

Meeting Requests, Manufacturer Assessments for NDAs and BLAs Subject of Draft Guidance\u2019s<\/strong><\/p>\n\n\n\n

The FDA published two draft guidance\u2019s focused on requirements for drug and biological approvals \u2014 one on formal meetings and one on alternative methods the agency may use to assess manufacturing facilities named in an NDA or BLA.<\/p>\n\n\n\n

FDA Broadens Pandemic-Era Guidance to Cover Trials During PHEs, Disasters<\/strong><\/p>\n\n\n\n

The FDA expanded the scope of its guidance on conducting clinical trials during the COVID-19 pandemic to apply to public health emergencies (PHE) and other disasters, issuing final guidance document that also includes several clarifications.<\/p>\n\n\n\n

Prescription Drug Use-Related Software Output Reviewed in Draft Guidance<\/strong><\/p>\n\n\n\n

The FDA published a draft guidance on how it intends to determine whether sponsor-provided prescription drug software output should be treated as FDA-required labeling or promotional labeling and how, or if, the corresponding software function should be described in the prescribing information (PI).<\/p>\n\n\n\n

Single Trial Can Support FDA Drug Approval, Says Draft Guidance<\/strong><\/p>\n\n\n\n

The FDA provided greater direction on demonstrating substantial evidence of effectiveness for drugs and biologics, publishing draft guidance on whether a single trial plus confirmatory evidence will suffice for a development program.<\/p>\n\n\n\n

FDA Final Guidance Tackles Human Factor Studies for Combination Products<\/strong><\/p>\n\n\n\n

The FDA\u2019s latest final guidance document features questions and answers on how to apply human factors (HF) engineering principles when developing combination products, clarifying how the uniqueness of these products affect HF engineering considerations for industry and agency staff. The 14-page document, \u201cApplication of Human Factors Engineering Principles for Combination Products: Questions and Answers,\u201d finalizes a draft guidance from February 2016 and should be used alongside the guidance\u2019s \u201cApplying Human Factors and Usability Engineering to Medical Devices\u201d and \u201cSafety Considerations for Product Design to Minimize Medication Errors,\u201d as well as other FDA product development guidance\u2019s, advised the agency.<\/p>\n\n\n\n

Human Factor Studies for Combination Products Tackled in FDA Final Guidance<\/strong><\/p>\n\n\n\n

The FDA\u2019s latest final guidance document features questions and answers on how to apply human factors (HF) engineering principles when developing combination products, clarifying how the uniqueness of these products affect HF engineering considerations for industry and agency staff.<\/p>\n\n\n\n

Biosimilar Draft Guidance\u2019s Tackle Labeling and Interchangeables<\/strong><\/p>\n\n\n\n

The FDA released two draft guidance\u2019s for biosimilar manufacturers \u2014 one on labeling that focuses on prescribing information and the other on the FDA\u2019s licensure requirements.<\/p>\n\n\n\n

FDA Manual of Policies and Procedures Updates ANDA Suitability Petitions<\/strong><\/p>\n\n\n\n

The FDA published a revision to its Manual of Policies and Procedures (MAPP) describing how the Office of Generic Drugs will track and respond to ANDA suitability petitions, consistent with the commitments made in the GDUFA III commitment letter.<\/p>\n\n\n\n

Cybersecurity Final Guidance Details System Considerations for Premarket Submissions<\/strong><\/p>\n\n\n\n

The increasing electronic exchange of health data through wireless, internet and networks along with the cybersecurity threats and vulnerabilities is driver for an FDA final guidance document making recommendations for cybersecurity information to be submitted with premarket applications to CDRH and CBER.<\/p>\n\n\n\n

Labeling of Ready-to-Use Prescription Drug Injectables Subject of FDA Guidance<\/strong><\/p>\n\n\n\n

Recommendations on labeling of injectable prescription drug product information submitted in an NDA or certain BLAs is the subject of an FDA guidance on dose banding.<\/p>\n\n\n\n<\/span>

\n

EUROPE<\/h2>\n\n\n\n

Explanatory note on pharmacovigilance fees payable to the European Medicines Agency<\/strong><\/p>\n\n\n\n

This note outlines the fees related to pharmacovigilance activities (and the rules of payments) that apply to medicinal products for human use authorized in the Union under Regulation (EC) No 726\/2004 and Directive 2001\/83\/EC. An increase in the level of fees (other than pharmacovigilance annual fees) to adjust for an inflation rate of 10.4% (related to 2022) and rounding off to the nearest EUR 10.  Increase in the level of pharmacovigilance annual fees to adjust for an inflation rate of 10.4% (related to 2022), with no rounding.<\/p>\n\n\n\n

Update on human variations web-based electronic application form implementation on product lifecycle management portal<\/strong><\/p>\n\n\n\n

The new web-based electronic Application Forms (eAF) in the new Product Lifecycle Management (PLM) portal will replace the current interactive PDF eAFs used for regulatory submissions. This is a first step towards making the form-filling and submission-handling process more efficient. The web-based Variations eAF for Human medicinal Centrally Authorized Products (CAPs) was released on 4 November 2022.<\/p>\n\n\n\n

Qualification of novel methodologies for drug development: guidance to applicants<\/strong><\/p>\n\n\n\n

The EMA qualification process is a new, voluntary, scientific pathway leading to either a CHMP Qualification opinion or a qualification advice on innovative methods or drug development tools. The qualification process addresses innovative drug development methods and tools. It will focus on the use of novel methodologies developed by consortia, networks, public\/private partnerships, learned societies and pharmaceutical industry for a specific intended use in pharmaceuticals R&D.<\/p>\n\n\n\n

IRIS guide for applicants<\/strong><\/p>\n\n\n\n

This guide was developed to show applicants how to use the IRIS platform to prepare and submit an application and\/or data for a scientific procedure (orphan designation application, scientific advice, ITF briefing meeting requests, marketing status reports, inspections and veterinary signal management) and related activities.<\/p>\n\n\n\n

User guide for the electronic application form for a Marketing Authorization<\/strong><\/p>\n\n\n\n

This user guide has been prepared in order to facilitate the work of applicants when completing the Electronic Application Forms (eAF) as part of an application for a marketing authorization of a medicinal product for human use \/ registration of a traditional herbal medicinal products.<\/p>\n\n\n\n

European Medicines Agency pre-authorization procedural advice for users of the centralized procedure<\/strong><\/p>\n\n\n\n

This guidance provides clarity on a number of questions which users of the centralized procedure may have. It offers an overview of the European Medicines Agency\u2019s position on issues, which are typically addressed during the course of pre-submission meetings.<\/p>\n\n\n\n

Good clinical practice (GCP) inspection procedures<\/strong><\/p>\n\n\n\n

ANNEX III and V of procedure for conducting gcp inspections requested by the chmp: computer systems have been updated.<\/p>\n\n\n

Tags: <\/mark><\/strong><\/span>Biotech Regulatory News<\/a>, <\/span>Combination Products<\/a>, <\/span>EU Regulatory News<\/a>, <\/span>Marketing Authorisation<\/a>, <\/span>Pharma Regulatory News<\/a>, <\/span>Regulatory News<\/a>, <\/span>USA Regulatory News<\/a><\/div>","protected":false},"excerpt":{"rendered":"

USA FDA Draft Guidance Pushes for Development of Stimulant Use Disorder Treatments With no FDA drug approvals to date for stimulant use disorder, the FDA published draft guidance outlining current recommendations for development programs and trial designs for treatment of moderate-to-severe cocaine use, methamphetamine use and prescription stimulant use disorder. Meeting Requests, Manufacturer Assessments for […]<\/p>\n","protected":false},"author":1,"featured_media":1951,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[639],"tags":[122,170,121,169,123,112,124],"class_list":["post-3536","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biopharma","tag-biotech-regulatory-news","tag-combination-products","tag-eu-regulatory-news","tag-marketing-authorisation","tag-pharma-regulatory-news","tag-regulatory-news","tag-usa-regulatory-news"],"yoast_head":"\r\nPharma\/BioTech - USA, Europe Regulatory News, Oct 2023 Vol. 1<\/title>\r\n<meta name=\"description\" content=\"News & updates from Pharma-Biotech industry and Regulatory bodies in USA & Europe\" \/>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"Pharma\/BioTech - USA, Europe Regulatory News, Oct 2023 Vol. 1\" \/>\r\n<meta property=\"og:description\" content=\"News & updates from Pharma-Biotech industry and Regulatory bodies in USA & Europe\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Vistaar\" \/>\r\n<meta property=\"article:published_time\" content=\"2023-10-10T09:02:00+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2025-11-03T10:17:57+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-content\/uploads\/2024\/01\/Biopharma-min.jpg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\r\n\t<meta property=\"og:image:height\" content=\"555\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\r\n<meta name=\"author\" content=\"admin\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\r\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/blog\\\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/blog\\\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\\\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/#\\\/schema\\\/person\\\/d62b304dd6b8cc3c3b5f77783874af43\"},\"headline\":\"Pharma\\\/Biotech – USA, Europe Regulatory News, Oct 2023 Vol. 1\",\"datePublished\":\"2023-10-10T09:02:00+00:00\",\"dateModified\":\"2025-11-03T10:17:57+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/blog\\\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\\\/\"},\"wordCount\":1005,\"image\":{\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/blog\\\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/wp-content\\\/uploads\\\/2024\\\/01\\\/Biopharma-min.jpg\",\"keywords\":[\"Biotech Regulatory News\",\"Combination Products\",\"EU Regulatory News\",\"Marketing Authorisation\",\"Pharma Regulatory News\",\"Regulatory News\",\"USA Regulatory News\"],\"articleSection\":[\"Biopharma\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/blog\\\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\\\/\",\"url\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/blog\\\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\\\/\",\"name\":\"Pharma\\\/BioTech - USA, Europe Regulatory News, Oct 2023 Vol. 1\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/blog\\\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/blog\\\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/wp-content\\\/uploads\\\/2024\\\/01\\\/Biopharma-min.jpg\",\"datePublished\":\"2023-10-10T09:02:00+00:00\",\"dateModified\":\"2025-11-03T10:17:57+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/#\\\/schema\\\/person\\\/d62b304dd6b8cc3c3b5f77783874af43\"},\"description\":\"News & updates from Pharma-Biotech industry and Regulatory bodies in USA & Europe\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/blog\\\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/blog\\\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/blog\\\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\\\/#primaryimage\",\"url\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/wp-content\\\/uploads\\\/2024\\\/01\\\/Biopharma-min.jpg\",\"contentUrl\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/wp-content\\\/uploads\\\/2024\\\/01\\\/Biopharma-min.jpg\",\"width\":1200,\"height\":555,\"caption\":\"Biopharma\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/blog\\\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Pharma\\\/Biotech – USA, Europe Regulatory News, Oct 2023 Vol. 1\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/#website\",\"url\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/\",\"name\":\"Vistaar\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/#\\\/schema\\\/person\\\/d62b304dd6b8cc3c3b5f77783874af43\",\"name\":\"admin\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/0d089543c02b6aad11bd03612ee5efc6ddd700450a82976e93b20516f42f6cf4?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/0d089543c02b6aad11bd03612ee5efc6ddd700450a82976e93b20516f42f6cf4?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/0d089543c02b6aad11bd03612ee5efc6ddd700450a82976e93b20516f42f6cf4?s=96&d=mm&r=g\",\"caption\":\"admin\"},\"sameAs\":[\"https:\\\/\\\/www.vistaar.ai\"],\"url\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/author\\\/admin\\\/\"}]}<\/script>\r\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Pharma\/BioTech - USA, Europe Regulatory News, Oct 2023 Vol. 1","description":"News & updates from Pharma-Biotech industry and Regulatory bodies in USA & Europe","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/","og_locale":"en_US","og_type":"article","og_title":"Pharma\/BioTech - USA, Europe Regulatory News, Oct 2023 Vol. 1","og_description":"News & updates from Pharma-Biotech industry and Regulatory bodies in USA & Europe","og_url":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/","og_site_name":"Vistaar","article_published_time":"2023-10-10T09:02:00+00:00","article_modified_time":"2025-11-03T10:17:57+00:00","og_image":[{"width":1200,"height":555,"url":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-content\/uploads\/2024\/01\/Biopharma-min.jpg","type":"image\/jpeg"}],"author":"admin","twitter_card":"summary_large_image","twitter_misc":{"Written by":false,"Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/#article","isPartOf":{"@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/"},"author":{"name":"admin","@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/#\/schema\/person\/d62b304dd6b8cc3c3b5f77783874af43"},"headline":"Pharma\/Biotech – USA, Europe Regulatory News, Oct 2023 Vol. 1","datePublished":"2023-10-10T09:02:00+00:00","dateModified":"2025-11-03T10:17:57+00:00","mainEntityOfPage":{"@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/"},"wordCount":1005,"image":{"@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/#primaryimage"},"thumbnailUrl":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-content\/uploads\/2024\/01\/Biopharma-min.jpg","keywords":["Biotech Regulatory News","Combination Products","EU Regulatory News","Marketing Authorisation","Pharma Regulatory News","Regulatory News","USA Regulatory News"],"articleSection":["Biopharma"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/","url":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/","name":"Pharma\/BioTech - USA, Europe Regulatory News, Oct 2023 Vol. 1","isPartOf":{"@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/#website"},"primaryImageOfPage":{"@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/#primaryimage"},"image":{"@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/#primaryimage"},"thumbnailUrl":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-content\/uploads\/2024\/01\/Biopharma-min.jpg","datePublished":"2023-10-10T09:02:00+00:00","dateModified":"2025-11-03T10:17:57+00:00","author":{"@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/#\/schema\/person\/d62b304dd6b8cc3c3b5f77783874af43"},"description":"News & updates from Pharma-Biotech industry and Regulatory bodies in USA & Europe","breadcrumb":{"@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/#primaryimage","url":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-content\/uploads\/2024\/01\/Biopharma-min.jpg","contentUrl":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-content\/uploads\/2024\/01\/Biopharma-min.jpg","width":1200,"height":555,"caption":"Biopharma"},{"@type":"BreadcrumbList","@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-oct-2023-vol-1\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/stage-websites.ddismart.com\/vistaar\/"},{"@type":"ListItem","position":2,"name":"Pharma\/Biotech – USA, Europe Regulatory News, Oct 2023 Vol. 1"}]},{"@type":"WebSite","@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/#website","url":"https:\/\/stage-websites.ddismart.com\/vistaar\/","name":"Vistaar","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/stage-websites.ddismart.com\/vistaar\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/stage-websites.ddismart.com\/vistaar\/#\/schema\/person\/d62b304dd6b8cc3c3b5f77783874af43","name":"admin","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/0d089543c02b6aad11bd03612ee5efc6ddd700450a82976e93b20516f42f6cf4?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/0d089543c02b6aad11bd03612ee5efc6ddd700450a82976e93b20516f42f6cf4?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/0d089543c02b6aad11bd03612ee5efc6ddd700450a82976e93b20516f42f6cf4?s=96&d=mm&r=g","caption":"admin"},"sameAs":["https:\/\/www.vistaar.ai"],"url":"https:\/\/stage-websites.ddismart.com\/vistaar\/author\/admin\/"}]}},"_links":{"self":[{"href":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-json\/wp\/v2\/posts\/3536","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-json\/wp\/v2\/comments?post=3536"}],"version-history":[{"count":5,"href":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-json\/wp\/v2\/posts\/3536\/revisions"}],"predecessor-version":[{"id":6537,"href":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-json\/wp\/v2\/posts\/3536\/revisions\/6537"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-json\/wp\/v2\/media\/1951"}],"wp:attachment":[{"href":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-json\/wp\/v2\/media?parent=3536"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-json\/wp\/v2\/categories?post=3536"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-json\/wp\/v2\/tags?post=3536"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}