Meetings

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 The current draft guidance is here and the meeting agenda is found here.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

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FDA workshop: Revising the process for importance-ranking of human antimicrobials to guide their use in animals

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

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FDA workshop: Insights on inhaled antifungals and antibacterials

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

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Job Opportunity with Duke-Margolis! / Phage workshop! / The Martian!

Dear All, I have many times previously shared webinars from the excellent policy team at Duke-Margolis Center for Health Policy. Excitingly if you are in search of that type of role, they are now looking for a Policy Analyst who would be located in either Washington, DC or Durham, NC. Here is the verbatim job summary from

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New meetings & grants, with a focus on Vietnam, China, and the UK

Dear All: Below my signature, find details of 4 new meetings and (collectively) 4 active or upcoming grant opportunities. One of the grants has a 6 Sep deadline, so look quickly! At the very bottom of the email you will find an integrated summary of all upcoming meetings … there is a lot going on!

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FDA workshop on complex innovative trial designs / WHO consultancy

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

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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

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