Dear All, Two things today — the first on using MICs and the second on re-using MICs. Read on! On using MICs (minimum inhibitory concentrations), we have additional details on the FDA BAA discussed in my 9 Oct 2023 newsletter, In particular, I’d like to draw your attention to a time-limited request regarding a request
Dear All, I’ve watched with interest the way that FDA’s CVM (Center for Veterinary Medicine) has been working steadily with the veterinary community as a whole to reduce antibiotic resistance pressure by improving the way antibiotics are used in animal care. The titles of these prior newsletters give you a feel for some aspects of
Dear All, Two quick items today. First, FDA have announced an Antimicrobial Drugs Advisory Committee on 17 April 2023 (9a-4.30p ET). The committee will “discuss new drug application (NDA) 216974, for sulbactam-durlobactam for injection, submitted by Entasis Therapeutics, Inc. The Applicant’s proposed indication is for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex including multidrug-resistant and
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 |
Dear All, It doesn’t rain … it pours! Just seconds after sending out a newsletter on the 18 May et seq. Squash Superbugs Day of Action, I learned that FDA has announced a 3 June 2022 workshop on uUTI! From their webpage on the event: “The workshop will focus on nonclinical and clinical considerations regarding antimicrobial
Dear All, Whew … still catching up after all the activities of World Antimicrobial Awareness Week (WAAW)! More to follow on some of that great content, but for today we have the news that FDA has posted 4 RFPs! All have due dates of 21 Jan 2022: Optimizing dosing strategies for obese patients and in continuous
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
Dear All, New on the meetings calendar today is the 10 Jan 2021 UCSF-Stanford Innovations in Regulatory Science Summit. Per the meeting website: “It is a gathering of leaders in the academia, industry and regulatory sectors to discuss the role of regulatory science in medical product development. “The 2021 Summit will have a major focus on
Dear All: A Federal Register notice has been released announcing a 16 Nov 2017 FDA Antimicrobial Drugs Advisory Committee meeting to review Bayer’s inhaled ciprofloxacin for reduction of exacerbations in adults with non-cystic fibrosis bronchiectasis with respiratory bacterial pathogens (NCFB). Post-meeting addendum: Materials from the meeting can be found here. You might also want to look at materials from
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