FDA

FDA Guidance: Coordinating susceptibility (AST) device approval with drug approval

Dear All: FDA has now posted a final guidance entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) Devices” that discusses the ways that FDA seeks to: Minimize lag time between drug approval and AST device* approval and Provide recommendations on how AST developers and drug developers can coordinate their work with each other and with

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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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6 Jun 2019 FDA AMDAC: Discussion of Pretomanid’s NDA for MDR-XDR TB

Dear All:  FDA today posted a Federal Register announcement of an Antimicrobial Drugs Advisory Committee (AMDAC) meeting on 6 June 2019. The AMDAC will discuss pretomanid (formerly, PA-824) tablets for oral administration, “proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive

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Clever pipeline visualization from Pew + New guidance documents from FDA

Dear All, Two very brief notes today… First, Pew Trusts continues to work to provide ways to understand the antibiotic pipeline. Building on their ongoing surveys (link), their latest contribution is a clever visualization tool that shows how antibiotics have moved forwards, backwards, and/or stopped during the period 2014-2018. Go here to see it in action and prepare to

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BARDA’s DRIVe goes live; FDA workshop (27 Jun!) on inhaled antibiotics

Dear All: I don’t mean to inundate your inbox (this is my 3rd email this week!), but these two things have just hit my inbox and one of them has very tight timing: First, I previously wrote about job opportunities with BARDA’s new DRIVe initiative. With the goal of revolutionizing the way we prevent, detect, and respond to major health security threats,

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