FDA

Two things: WHO’s looking GLASS + FDA’s advances with PDUFA VI

Dear All: Two things today. Unrelated, but both relevant! WHO’s GLASS: WHO’s Global Antimicrobial Resistance Surveillance System (GLASS) was created during October 2015 and seeks to obtain coordinated and consistent global estimates on resistance rates. In a major report released on 29 Jan 2018, GLASS now provides provides official national AMR data for the period 2016-17 from 40 countries

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FDA offers 2 fellowships and 3 RFPs! Endpoints, breakpoints, PROs & more!

Dear All, Our colleagues at FDA are planning some serious AMR-related research during 2021-22 with the following fellowships and RFPs. Extended details are available via the links — you can also find brief summaries below my signature or via FDA’s research webpage. Wow! FDA Fellowship #1: A study of ordinal endpoints for antibiotic trials using

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FDA-NIAID phage workshop / Social distancing in the 1800s

Dear All, This webinar merits a standalone newsletter! If you are thinking (or working on) phage, then please mark your calendar for an FDA (CBER; Center for Biologics Evaluation and Research) workshop entitled: Science and Regulation of Bacteriophage Therapy: August 30, 2021—September 1, 2021 The purpose of the public workshop is to exchange information with the

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FDA workshop: Revising the process for importance-ranking of human antimicrobials to guide their use in animals

Dear All, FDA have announced that they will hold a virtual public workshop on 16 Nov 2020 (9.30a-4.00p EST) entitled “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.” Go here for the FR notice, here for extended details, including registration, and here for

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FDA workshop: Clinical trial designs for agents for non-tuberculous mycobacterial infection on 8 Apr 2019

 REDear All: I just heard to today that FDA is holding a public workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease” on 8 April 2019 from 8.30a-5.00p. Register here. Per their website, “the purpose of the public workshop is to discuss the clinical trial design considerations, including endpoints, related to the

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FDA and EMA regulatory updates / Fireside chat during the 4th AMR Conference

Dear All (lots and lots of wonkish detail here, be sure your blood caffeine level is adequate!), During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference (go here or see below my signature for more), I had the opportunity on 27 August to chat with Sumati Nambiar (FDA) and Marco Cavaleri (EMA) about ongoing regulatory activities. The

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FDA workshop: Insights on inhaled antifungals and antibacterials

Dear All (wonkish alert … coffee up!), FDA held a workshop on 25 Sep 2020 on development of inhaled antifungal (AF) therapies with a focus on (i) therapies for allergic bronchopulmonary aspergillosis (ABPA) and severe asthma with fungal sensitization (SAFS), (ii) prophylaxis in lung transplantation, and (iii) adjunct therapy in invasive fungal lung infections (link to

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18-19 Nov 2019 FDA-IDSA-NIH-Pew Workshop: Enhancing Antibacterial Trials in the US

Dear All, Long note alert: Set aside at least 30 minutes for this one … there’s a lot of important material here. Last week’s workshop entitled “Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States” was an unusual and unusually instructive meeting. You can go here for the meeting materials but as there are

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