Government Action

EU Joint Action on AMR & Health-Care Associated Infections (EU-JAMRAI): Passing the DRIVE-AB torch?

Dear All: Recently announced is a new EU Joint Action on Antimicrobial Resistance (AMR) & Health-Care Associated Infections (HCAI). Its acronym is EU-JAMRAI and the website is https://eu-jamrai.eu/. Joint actions are a common tool for coordinating implementation activities across Europe. EU-JAMRAI actually started in September 2017 and will run for three years but it is really

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Your vote counts! Support the UN proposal for an AMR-focused Sustainable Development Goal (SDG) Indicator

Dear All, Your vote counts! The UN’s Inter-Agency and Expert Group on Sustainable Development Goal Indicators (IAEG-SDGs) is conducting an open consultation on proposals it is considering including in the 2020 Comprehensive Review and is seeking the global community’s comments on these proposals (link to summary web page). The 17 SDGs were adopted in 2015 and are really driving

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Lord O’Neill’s 10 steps to control AMR, two years on / G20 calls for action

Dear All: About two years ago, Lord Jim O’Neill led the UK AMR review to its 7th and final report and proposed these 10 steps as the fundamental basis for controlling AMR: A massive global public awareness campaign Improve hygiene and prevent the spread of infection Reduce unnecessary use of antimicrobials in agriculture and their dissemination into the environment Improve global surveillance of drug resistance and antimicrobial consumption in humans and animals

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The UK jumps in with a subscription model for antibiotics!

Dear All: We had hints back in January that this was coming (see this post), but now it is really happening! In brief, UK’s NHS will test the world’s first subscription-style payment model in which payments delinked from volume are used to incentivise pharmaceutical companies to develop new drugs for resistant infections. Below my signature, I’ve

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Updated EMA antibacterial guidance: Draft released for public consultation

Dear All: Dated 19 Dec 2018 and marked as released for public consultation on 14 Jan 2019, EMA has posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft antibacterial guidance document. I have not yet had a chance to study in detail and will

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Updates from EMA, FDA, and UK NICE at the 6-8 Sep 2017 ASM-ESCMID Antibiotic Development Conference

Dear All: On Wednesday 6 Sep at the ASM-ESCMID Conference on Antibacterial Development, we heard 3 superb back-to-back talks on the evolving regulatory and health technology assessment (HTA) landscape. The speakers (Marco Cavaleri, PhD, Head of Anti-Infectives and Vaccines, EMA; Sumati Nambiar, MD, Director, Division of Anti-infective Products, FDA; and Colm Leonard, MD, Consultant Clinical Adviser,

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EMA-FDA-PMDA action + Podcasts (CDD, Pew) + NEJM on non-inferiority

Dear All: Several updates today, all on the theme of good things to know or share! First, EMA, FDA, and PMDA are continuing to meet and have released a summary of their third tripartite meeting. The key message is alignment: alignment on trial designs for key indications, alignment on pediatric programs, and alignment on single global development programs! This is

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Draft EMA antibacterial guidance: Analysis

Dear All: I wrote previously that EMA posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft antibacterial guidance document. I’ve now had a chance to read it in detail and thought I would share my thoughts as a way to provoke discussion. As a reminder, the

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New European Action Plan on AMR

Dear All: ​An updated European One Health Action Plan on AMR was released today. See links and text excerpts below my signature. The plan builds on the 2011-2016 Action Plan on AMR and foresees more than 75 actions built on three main pillars. Here’s a Table of Contents excerpt that gives you a quick overview: 1.

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