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John Rex

FDA guidance on Substantial Effectiveness; EMA concept paper on Evaluation of Antifungal Agents): Comments sought!

Dear All: Both FDA and EMA have very recently released important documents for comment. See below the links and commentary on the two documents. == FDA: The Substantial Evidence guidance, further updated: Comments due 22 Sep 2026 ==FDA have released a further revision of their Dec 2019 draft guidance entitled “Demonstrating Substantial Evidence of Effectiveness

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5 July 2026 No Comments

WHO Webinars: Pediatric antibiotic R&D and Bacteriophage Community of Practice

Dear All: Two important webinars have just been announced! 22 July (virtual, 2-3.30p CET): The WHO AMR Department and the WHO GAP-r (Global Accelerator for Pediatric Formulations) are hosting an industry dialogue on pediatric and neonatal antibiotic development: The discussion will cover timing of pediatric and neonatal studies, extrapolation from adult data, feasibility of trial

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3 July 2026 No Comments

CDC: Funding opportunities (1 each) in US, Africa, and Asia

Dear All: CDC have recently posted this eclectic mixture of funding opportunities that circle the globe!  Funding opportunity: CDC-RFA-CK-26-0107 Title: “Building National Partnerships for the Prevention of Emerging and Reemerging Infectious Diseases“ Brief description: Seeks to build capacity in the United States to prevent, detect, and respond to infectious disease threats by building and sustaining

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2 June 2026 No Comments

PACCARB returns! 16 June 2026 virtual meeting

Dear All: Without much fanfare, we have an announcement that PACCARB (the US Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria) is being revived at a 16 June 2026 virtual meeting! Here are the links you need: 19 May 2026 Federal Register notice DHHS webpage about the meeting Date and time: 16 June 2026, 12.30-3.30p ET

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30 May 2026 No Comments

EUR 20m funding for next-gen diagnostics for LRTIs (Novo Nordisk Foundation)

Dear All: I have just learned of a recently opened grant program from NNF (Novo Nordisk Foundation) that seeks to fund early-stage proof-of-concept on rapid, minimally invasive and affordable testing for LRTIs ((Lower Respiratory Tract Infections) at the point-of-care in global settings. The grant program actually opened just after ESCMID and I missed the announcement

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28 May 2026 No Comments

Economic modeling of the value of rapid diagnostics

Dear All (and again with thanks to Arjun Srinivasan for co-authoring this pair of newsletters): In parallel with the newsletter discussing a recent paper on the impact of rapid antimicrobial susceptibility testing (27 May 2026 newsletter, “Limits on measuring the impact of rapid AST”), we have release of an exceptionally well-done classic economic approach showing

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27 May 2026 No Comments

BARDA seeks info on Phase 2+ antifungals for Candida and Aspergillus

Dear All: As discussed in prior newsletters, BARDA is constantly working to ensure it has adequate medical countermeasures (MCMs) for a variety of possible threats. The titles of these newsletters give a quick review of their recent work — note in particular the Fireside Chat and the newsletter discussing the ongoing BAA (Broad Agency Announcement)

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22 May 2026 No Comments

CARB-X seeks two Assistant Directors of External Affairs

Dear All: Starting to get caught up after some time on vacation! For today, we have announcement by CARB-X of the posting of two openings for the role of Assistant Directors of External Affairs. Here are the links: Official webpage: https://jobs.silkroad.com/BU/External/jobs/316699 LinkedIn post: https://www.linkedin.com/posts/damianodefelice_job-opportunity-vacancy-share-7461081369562066944-tS7O A few excerpts from the job description: “The Assistant Director of

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18 May 2026 No Comments
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