Dear All: As you know if you are a regular reader of this newsletter, I think that creation of suitable Pull incentives by passage of the PASTEUR Act in the United States is key to building a vibrant pipeline of products to address the international problem of AMR. I’ve also written recently about the FORWARD Act
Dear All: Also appearing today are two valuable opportunities to comment on key global strategy documents. I do hope each of you can make time to look at these materials and consider sending in your thoughts — it really does make a difference when central leadership groups hear from a broad array of stakeholders! First, EMA has
Update on 11 October 2023: The annual BARDA Industry Day is 13-14 November 2023! You can attend virtually or in person at the Grand Hyatt Washington, DC. Click here for more details! Dear All, Hot on the heels of the BAA from BARDA and from ARPA-H, we now have a Broad Agency Announcement from the FDA! There
Dear All, As has been discussed in recent newsletters (link), the UK National Institute for Health and Care Excellence (NICE) and NHS England launched a joint project July 2019 to test a payment model for antibiotic products, based on a product’s value to the NHS, rather than how much is used. This goal of the
Dear All, This one slipped past me until just now … EMA have released a concept paper entitled “Development and manufacture of human medicinal products specifically designed for phage therapy – Scientific guideline.” Here are the links you need: Overview webpage regarding the concept paper The 4-page concept paper itself A parallel guidance on phage for veterinary purposes
This is the third of a 4-part newsletter series. There is an initial 27 Sep 2023 newsletter introducing the EPA concept note, a second (28 Sep 2023) newsletter that expands on the EPA concept note, and finally a 4th newsletter (27 Jan 2024) containing some additional resources. Dear All, Your alert co-reader in Australia (Christine Carson at U Western Australia), wrote recently to alert
This is the second of a 4-part newsletter series. There is an initial 27 Sep 2023 newsletter introducing the EPA concept note, a third (12 Jan 2024) newsletter about ending the use of streptomycin spray on citrus crops, and finally a 4th newsletter (27 Jan 2024) containing some additional resources. Dear All (OK, so now it’s 5 newsletters in as
This is the first of a 4-part newsletter series. There is a second (28 Sep 2023) newsletter that expands on the EPA concept note, a third (12 Jan 2024) newsletter about ending the use of streptomycin spray on citrus crops, and finally a 4th newsletter (27 Jan 2024) containing some additional resources. Dear All, What
Dear All (and with thanks to Kevin for co-authoring), The UK NHS England Pilot is known to us all as the first real attempt at an antibiotic subscription model and now it will be undergoing a major overhaul. In case you are a new reader or would like a refresher on the pilot, here are the links
Dear All, As a follow up the 19 Aug 2023 newsletter on MHLW’s work on Pull incentives (and with thanks to Yann Ferrise of GARDP for pointing out this out), we have an update in the 7 Aug 2023 edition of Nikkan Yakugyo (https://nk.jiho.jp/article/183026). It’s in Japanese and so again I must apologize for my lack
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