Government Action

A Nature Article, a PASTEUR Act Op-Ed, and a VERY Important Phone Number

Dear All, First, Nature published an excellent article entitled “The importance of antimicrobial resistance in medical mycology” by Gow et al. The first sentence of the introduction really packs a punch — “The age of antibiotics, spanning only 80 years, is now entering a period of progressive and widespread emergence of drug-resistant organisms that threaten to bring

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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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WHO Tripartite Joint Secretariat on AMR seeks consultant to develop multisectoral guidance

Dear All, WHO continues on their streak of seeking support for their AMR-related work! Today we have a posting by the Tripartite Joint Secretariat on Antimicrobial Resistance (AMR) of a consultancy opening for an 11-month project that would support development of multisectoral guidance(s) on development and strengthening of the coordination mechanisms and governance structures for addressing AMR. Full details

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WAAW! Must-Read Article, A Quiz, A Video, A Call to Action

Notes: Newsflash … BARDA have opened their long-running BAA-18-100-SOL-00003 to include support for antifungal agents. Search for “antifungal” in the posted .pdf to find the text. The first deadline for proposals is 15 Dec 2022 and further deadlines will doubtless follow: as shown on page 9, this BAA has offered 4 deadlines/year since 2018!  Dear All, In

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NHS England antibiotic procurement pilot project: Update webinar on 25 Mar 2020

Dear All, This email was just today received from the team leading the NHS England antibiotic procurement project (go here for a prior newsletter describing the project): Dear Stakeholders, In November 2019, we held a stakeholder webinar to share our response to the comments raised in targeted engagement  and to outline proposals for the procurement process.

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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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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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The UK commits to a delinked antibiotic purchase model!

Dear All: Wow! It’s happened! As reported this morning in The Times and The Guardian among others, the UK will announce at Davos that it is committing to a 20-year vision and initial 5-year plan to combat AMR. The plan includes actions to reduce infection rates, to reduce antibiotic use, and most importantly for this audience to find a path to delinked

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Let’s make a pull incentive happen in the US during the 116th Congress!

Dear All: I’ve written a lot about the need for pull incentives, preferably delinked (some papers to read, comments by TATFAR, highlights from Davos 2018, and the UK commits to trying delinkage).  Now, I am delighted to report that a really serious effort is underway in the US to make something happen during the 116th Congress. The essential document can be

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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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