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, 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

Addendum: This is the first in a 3-newsletters series on this topic. Go here and here for the next two newsletters. Finally, the results of the STRIVE trial have been published as Hassanzadeh et al. in Clinical Infectious Diseases, ciad218, https://doi.org/10.1093/cid/ciad218. Dear All:  I just learned that FDA’s Vaccines and Related Biological Products Committee (VRBPAC) will meet at

Addendum: This is the second in a 3-newsletters series on this topic. Go here for the first newsletter and here for the final newsletter. Finally, the results of the STRIVE trial have been published as Hassanzadeh et al. in Clinical Infectious Diseases, ciad218, https://doi.org/10.1093/cid/ciad218. Dear All:  I wrote on 19 Oct 2017 about the meeting on 7 Nov 2017

Addendum: This is the third in a series of newsletters on IM bacitracin. Go here for the prior newsletter and here for the 4th and final newsletter. Aside: I can’t comment on it in detail today, but do note that IACG (Interagency Coordination Group on AMR) have just released their final report to the UN Secretary