Dear All (lots and lots of wonkish detail here, be sure your blood caffeine level is adequate!), During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference (go here or see below my signature for more), I had the opportunity on 27 August to chat with Sumati Nambiar (FDA) and Marco Cavaleri (EMA) about ongoing regulatory activities. The
Dear All, We learned today during the BEAM AMR conference (link) that EMA released a call on 7 June 202 for comments on their draft Network Strategy to 2025 that considers how “the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges
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
Note that there is a follow-up newsletter that covers a post-webinar FAQ. After reading this newsletter as introduction, please go here for the follow-up newsletter. Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Prior newsletters have covered the antibiotic evaluation procurement pilot being run by NICE and NHS England (go here for the
Dear All, Kevin Outterson and I recently shared our analysis of the NICE/NHS England pilot of an antibiotic procurement subscription model (link to that newsletter). The NICE/NHS team have now released a post-webinar FAQ document. Here is the link to the document … and I’ve also added the link to the initial webpage (cited just above) discussing
Dear All: I’ve written a lot about the need for pull incentives, preferably delinked (some papers to read, comments by TATFAR, highlights from Davos 2018, and the UK commits to trying delinkage). Now, I am delighted to report that a really serious effort is underway in the US to make something happen during the 116th Congress. The essential document can be
Dear All: Dated 19 Dec 2018 and marked as released for public consultation on 14 Jan 2019, EMA has posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft antibacterial guidance document. I have not yet had a chance to study in detail and will
Dear All: Wow! It’s happened! As reported this morning in The Times and The Guardian among others, the UK will announce at Davos that it is committing to a 20-year vision and initial 5-year plan to combat AMR. The plan includes actions to reduce infection rates, to reduce antibiotic use, and most importantly for this audience to find a path to delinked
Dear All: I wrote previously that EMA posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft antibacterial guidance document. I’ve now had a chance to read it in detail and thought I would share my thoughts as a way to provoke discussion. As a reminder, the
Note: Be sure to see the forward calendar: there is a webinar on 9 May during which Mark McClellan will speak with Sen. Todd Young, co-sponsor of the recently reintroduced PASTEUR Act! Don’t miss it! Dear All, For today’s note, we will be doing a dive into some very exciting AMR-related proposed legislation released by
