By Ramsey Baghdadi
Q: The RPM Report: How has FDA changed over the last five to ten years? Is it your view that...
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The Regulator and the Regulated Part I: A Conversation with FDA's Robert Temple and Amgen's Roger Perlmutter
FDA’s dean of drug development Robert Temple and Amgen’s head of research and development Roger Perlmutter sat down for a conversation at the recent FDA/CMS Summit to discuss opportunities and challenges for biopharmaceutical developers in the current regulatory environment.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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Health Canada has approved four new drugs and 12 label variations so far this year via Project Orbis, a combined figure that already exceeds the annual approval figures for the two previous years. The agency explains the factors that impact annual approvals and highlights the pathway’s benefits.
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include three new products, one of which is Rezdiffra, Madrigal Pharmaceuticals’s treatment for metabolic dysfunction-associated steatohepatitis.
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The UK’s medicines regulator wants to ensure that guidance on the use of artificial intelligence in pharmacovigilance processes remains fit for the future.