FDA

Pew’s SPARK goes live / FDA on Master Protocols and Adaptive Designs / CDC’s Fungal Awareness Week

Dear All: Potpourri! Four things of note… First, Pew’s SPARK (Shared Platform for Antibiotic Research and Knowledge) has now gone live. Seeking to address a core issue in Pew’s Scientific Roadmap for Antibiotic Discovery, SPARK is a cloud-based sharing tool for data on how molecules enter and stay inside of Gram-negative bacteria. To learn more, mark your calendar

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FDA workshop on non-traditional antibacterials (21-22 Aug 2018)

 Please be sure to look closely at the events calendar: Q&A with Scott Gottlieb, Lipinski on Lipinski, and more! Dear All: FDA’s 21-22 Aug 2018 workshop on the development of non-traditional antibacterial agents was an excellent discussion of core challenges in this area. The agenda plus all the meeting materials (including the public comment slides and

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Commissioner Gottleib (New FDA initiatives, need for Pull incentives) + updated Pew pipeline analyses

Dear All: It was a HUGE day at the Pew Charitable Trusts today! First, Commissioner Scott Gottleib gave a superb and very exciting speech. You can either read or listen to the entire speech. There is also a panel discussion after his talk that is worth replaying. Here are some highlights from Commissioner Gottleib’s talk: FDA is working to coordinate

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Five FDA RFPs! Antifungal animal models, MIC breakpoints, and more!

Dear All, I just today learned that FDA have posted their FY 2023 funding opportunities. All the details are on this webpage and I’m just going to reproduce the text below my signature for your reference. I’ll also add a few details in italics. Lots of good opportunities here! –jr John H. Rex, MD |

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FDA workshop: Animal models to support antibacterial development (5 Mar 2020)

Dear All (moderately long note alert; be sure to note the new list of funding opportunities just below my signature), FDA have announced a public workshop on 5 Mar 2020 to discuss progress and challenges in the development and advancement of various animal models for serious infection. The Federal Register notice is here and registration is here.

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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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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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