27 March 2024 No Comments
Meetings
FDA workshop on non-traditional antibacterials (21-22 Aug 2018)
Please be sure to look closely at the events calendar: Q&A with Scott Gottlieb, Lipinski on Lipinski, and more! Dear All: FDA’s 21-22 Aug 2018 workshop on the development of non-traditional antibacterial agents was an excellent discussion of core challenges in this area. The agenda plus all the meeting materials (including the public comment slides and
23 August 2018 No Comments
18-19 Nov 2019 FDA-IDSA-NIH-Pew Workshop: Enhancing Antibacterial Trials in the US
Dear All, Long note alert: Set aside at least 30 minutes for this one … there’s a lot of important material here. Last week’s workshop entitled “Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States” was an unusual and unusually instructive meeting. You can go here for the meeting materials but as there are
27 November 2019 No Comments
FDA workshop: Clinical trial designs for agents for non-tuberculous mycobacterial infection on 8 Apr 2019
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
4 March 2019 No Comments
Public meeting on the LPAD Pathway: Post-meeting thoughts (wonkish)
Long and wonkish note alert — please refresh your coffee before you start reading! Dear All: I was able to attend and speak at the 12 July 2019 Public Meeting organized by FDA on the LPAD (Limited Population Antibacterial and Antifungal Drug) pathway. The current draft guidance is here and the meeting agenda is found here. The meeting
22 July 2019 No Comments
FDA Workshop: Animal Models To Support Antibacterial Development (5 Mar 2020, post-meeting notes)
Dear All (detailed and wonkish note alert … lots of thinking out loud … get some coffee and settle in!), I wrote previously (link) about FDA’s planned workshop on animal models to support antibacterial development and I was able to listen to the workshop via webcast. As brief context (and please be sure to look
8 March 2020 No Comments
FDA workshop: Animal models to support antibacterial development (5 Mar 2020)
Dear All (moderately long note alert; be sure to note the new list of funding opportunities just below my signature), FDA have announced a public workshop on 5 Mar 2020 to discuss progress and challenges in the development and advancement of various animal models for serious infection. The Federal Register notice is here and registration is here.
4 February 2020 No Comments
12 July 2019 FDA public meeting for comments on the 2018 LPAD guidance
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
1 April 2019 No Comments
FDA workshop on development of therapies for non-tuberculous mycobacterial (NTM) disease
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
12 April 2019 No Comments
FDA Workshop: Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes
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
10 June 2019 No Comments
