FDA Archives • AMR.Solutions

17 April 2023: FREE Masterclass from FDA / CARB-X wants you!

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

17 March 2023 No Comments

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 |

28 November 2022 No Comments

Antibacterial guidance (including pediatrics): Parallel EMA+FDA updates

Dear All (Wonkish alert! Get some coffee and settle in!), Almost in parallel, EMA and FDA have released updates to key antibacterial guidance documents! Here are the links you’ll need and I’ve highlighted the key documents. To go deeper, you’ll need to pick through everything and I provide a tour further below in this newsletter: EMA’s

27 May 2022 No Comments

3 June 2022 FDA workshop: Developing for uncomplicated UTI (uUTI)

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

17 May 2022 No Comments

FDA posts 4 RFPs! MIC breakpoints, PRO for ABPA, dosing in obesity/CRRT!

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

2 December 2021 No Comments

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

12 October 2020 No Comments

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

18 October 2020 No Comments

FDA AdComm #2 on inhaled ciprofloxacin (11 Jan 2018); IMI Call for AMR diagnostics (28 Feb 2018 deadline)

Dear All: Two new events on the near-term horizon. First, FDA has announced an Antimicrobial Drugs Advisory Committee for 11 Jan 2018 (and materials from the meeting can now be found here). Per the FR notice, this AMDAC will cover Aradigm’s inhaled ciprofloxacin for non-CF bronchiectasis and is almost certainly a discussion of the results Aradigm’s ORBIT-3

3 December 2017 No Comments

FDA-NIAID-CDC: Developing drugs for gonorrhea, 23 Apr 21 workshop

Dear All, FDA, NIAID and CDC have announced a public workshop on development considerations of antimicrobial drugs for the treatment of gonorrhea. The workshop will cover both nonclinical (preclinical) and clinical trial design considerations: Animal models Clinical pharmacology considerations Trial design considerations for gonorrhea, such as enrollment strategies, choice of comparators and site of infection.

13 April 2021 No Comments

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

8 January 2021 No Comments

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