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 (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
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
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
Dear All, This webinar merits a standalone newsletter! If you are thinking (or working on) phage, then please mark your calendar for an FDA (CBER; Center for Biologics Evaluation and Research) workshop entitled: Science and Regulation of Bacteriophage Therapy: August 30, 2021—September 1, 2021 The purpose of the public workshop is to exchange information with the
Dear All, Some regulatory updates today. From FDA, we have final versions of their CABP and HABP-VABP guidance documents. My initial review suggests no big changes: CABP (Community-Acquired Bacterial Pneumonia) The draft from Jan 2014 has been updated with a final version dated June 2020 (link). I generated a comparison between the two (link). The
Dear All (wonkish note alert … top-up your coffee and settle in!), Today we have a tour of a recent paper in Clinical Infectious Diseases in which FDA presents a very instructive analysis of endpoints used in recent CABP (Community-Acquired Bacterial Pneumonia) trials and how data such as these might permit further convergence of global