FDA Archives • AMR.Solutions

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 and EMA regulatory updates / Fireside chat during the 4th AMR Conference

Dear All (lots and lots of wonkish detail here, be sure your blood caffeine level is adequate!), During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference (go here or see below my signature for more), I had the opportunity on 27 August to chat with Sumati Nambiar (FDA) and Marco Cavaleri (EMA) about ongoing regulatory activities. The

14 September 2020 No Comments

Final FDA LPAD guidance: Same substance, useful clarifications

Dear All, FDA have released the final version of their LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs, really should be LPPAAAD) guidance. You can get it here. I have generated a comparison with the Jul 2018 draft version that you can get here. As a reminder, the central concept of the LPPAAAD pathway

6 August 2020 No Comments

A new BAA, now from FDA!

Update on 11 October 2023: The annual BARDA Industry Day is 13-14 November 2023! You can attend virtually or in person at the Grand Hyatt Washington, DC. Click here for more details! Dear All, Hot on the heels of the BAA from BARDA and from ARPA-H, we now have a Broad Agency Announcement from the FDA! There

9 October 2023 No Comments

Using/Reusing MICs: FDA seeks urine-specific breakpoints; Vivli surveillance data awardees

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

20 October 2023 No Comments

Appropriate duration of antimicrobial dosing in food animal care

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

26 September 2023 No Comments

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

AMR.Solutions

FDA