Dear All: The idea of using real-world evidence (RWE) as a way to support development of novel agents (including antibiotics!) has always intrigued. As you may recall, the 21st Century Cures Act (Cures Act) gave FDA a mandate to evaluate the potential use of RWE to support drug approval. There was a workshop on this on
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
Dear All: FDA today posted a Federal Register announcement of an Antimicrobial Drugs Advisory Committee (AMDAC) meeting on 6 June 2019. The AMDAC will discuss pretomanid (formerly, PA-824) tablets for oral administration, “proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive
Dear All: FDA held a workshop (go here for workshop agenda and materials) on 8 Apr 2019 on “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease.” I attended by webcast and worked with an on-the-spot attendee (David Melnick of Spero Therapeutics) to develop this summary. The workshop started with a review of the underlying
Addendum: This is the second in a series of newsletters on IM bacitracin. Go here for the prior newsletter and here for the next newsletter. Dear All: Two somewhat overlapping ideas at the start of the week: First, FDA today announced a funding opportunity and Request for Applications (RFA) for studies that can help target and define durations
Dear All: Apologies for the back-to-back emails, but this one just came across the transom. In brief, FDA will hold a public meeting on Friday 12 Jul 2019 (9a-3p EDT, FDA White Oak Campus) at which FDA is soliciting public comment on the 2018 LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs) guidance. You can register
Addendum: This is the first of a series of newsletters on IM bacitracin. Go here for the next newsletter. Dear All: FDA has announced that on 26 April (8:30a-1:00p) it will have an Antimicrobial Drugs Advisory Committee to “… discuss the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and
Dear All: Two things on a Friday: First, I just learned of IDSA’s release of its latest paper (link) in the Bad Bugs/No Drugs and 10×20 series. Officially entitled “The Infectious Diseases Society of America’s 10 × ’20 Initiative (Ten New Systemic Antibacterial Agents FDA-approved by 2020): Is 20 × ’20 a Possibility?”, I think a
REDear All: I just heard to today that FDA is holding a public workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease” on 8 April 2019 from 8.30a-5.00p. Register here. Per their website, “the purpose of the public workshop is to discuss the clinical trial design considerations, including endpoints, related to the
Dear All: Here’s a potpourri today of several new entries in the forward meetings list below my signature. First, the US FDA will meet with CDSCO (Central Drugs Standard Control Organization, the Indian equivalent of FDA & EMA) in a workshop in Mumbai on 8 Mar. More details here! It’s great to see the global regulatory agencies continuing