R&D Insight

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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NIAID seeks your comments as it updates its strategic research framework

Dear All: In 2014, NIAID set out a 5-year strategic framework for research on Antimicrobial Resistance (download it here). That document laid out these 7 areas for intensive efforts to combat AMR: Systems Biology and Antibacterial Resistance: New Directions for Drug Discovery–Using a holistic approach to examine molecular networks of host-pathogen interactions and global changes in response to

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NDM-1 in the Arctic / IACG seeks your views!

Dear All: Apologies for inundating with updates … the last few days have been very data rich! In case you missed it, McCann et al. (Env Internat, “Understanding drivers of antibiotic resistance genes in High Arctic soil ecosystems,” link) have found NDM-1, one of our more famous recent resistance genes, in the Arctic. As they state in their abstract, “The

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WHO wants to hear from all pre-clinical antibiotic developers (18 Mar 2019 deadline)

​Dear All: Are you doing preclinical antibiotic R&D? If so, WHO wants to hear from you! As you know, WHO has published these two analyses of priority pathogens and antibacterial agents currently in Phases 1-3: Prioritization of pathogens to guide discovery, research and development of new antibiotics for drug resistant bacterial infections, including tuberculosis (2017, link) 

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12 July 2019 FDA public meeting for comments on the 2018 LPAD guidance

Dear All: Apologies for the back-to-back emails, but this one just came across the transom. In brief, FDA will hold a public meeting on Friday 12 Jul 2019 (9a-3p EDT, FDA White Oak Campus) at which FDA is soliciting public comment on the 2018 LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs) guidance. You can register

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FDA Antimicrobial Drugs Advisory Committee (AMDAC) on 26 Apr 2019: IM Bacitracin for staphylococcal pneumonia and empyema in infants?!

Addendum: This is the first of a series of newsletters on IM bacitracin. Go here for the next newsletter. Dear All: FDA has announced that on 26 April (8:30a-1:00p) it will have an Antimicrobial Drugs Advisory Committee to “… discuss the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and

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Upcoming BARDA RFP to acquire antibiotic(s) for biothreat indications!

Dear All: Ready, set, (get ready to) go! I just today learned of this really important US government pre-solicitation notice (lightly reformatted excerpt follows, see here for the whole thing): “The Government seeks an FDA-approved antibiotic(s) for a biothreat indication (Y. pestis, B. anthracis, F. tularensis, B. mallei and/or B. pseudomallei) for delivery to the Office of the Assistant Secretary for Preparedness and Response

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