Dear All, Please mark your calendar now to be in the Washington, DC area on 18-19 Nov 2019 for a 2-day workshop at FDA’s White Oak Campus focused on enhancing the clinical trial enterprise for antibacterial drug development. Jointly co-sponsored by FDA, IDSA, NIAID, and Pew Trusts, this meeting will have a particular focus on (a)
Dear All, On 4 Nov 2019 at their White Oak Campus, FDA will hold a public hearing from 9a-4p on fecal microbiota transplantation (FMT) to treat Clostridium difficile infections that are not response to standard therapies. Go here for the online FR notice and here for the .pdf version. The background on this topic goes back several years and is well
Dear All: Per an email received today, there will be an FDA Grand Rounds webcast on 14 Sep 2017 (noon-1p EST) in which FDA unveils a new paradigm for evaluating the cardiac safety of new drugs entitled the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative. Here is the link to the FDA webpage where you can get further details
Dear All: There is a newly announced FDA workshop on 13 Sep on using real-world evidence. Here is the link and I’ve also reproduced the key background text below my signature. This is of interest to the antibacterial community as our reliance on non-inferiority trials for the majority of our data means that we are often going to want
Dear All: FDA today hosted their eagerly awaited workshop on animal models in support of narrow-spectrum agents for A. baumannii (Abau) and P. aeruginosa (Pae). It was a really full & interesting day at the end of which my confidence that we can actually register narrow-spectrum agents for these two pathogens (and others that are even less frequent) is
Dear All (and with apologies … long note alert!): Yesterday’s AMDAC was very productive. For reference, all the materials are here and a reasonably detailed set of notes are found below my signature. For further color, David Shlaes has also posted a summary on his Perfect Storm blog. FDA nicely positioned the question for the day as “It will