Dear All, An updated version of FDA’s very helpful Q&A entitled “Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers” has just been released. Here are the links you need to get started: The new June 2025 guidance itself The webpage about the guidance
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
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
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 (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
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, First up today is a very interesting new workshop from FDA on 1-2 Sep entitled “Advancing the Development of Pediatric Therapeutics (ADEPT 7) Complex Innovative Trial Design.” In brief: “The Complex Innovative Trial Design Pilot Meeting Program (CID Program) facilitates and advances the use of complex and innovative trial designs that have the potential