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New mechanisms for antibiotic reimbursement in the United States: CMS’s IPPS FY2020 Final Rule

Dear All (and with thanks to Kevin Outterson for substantial help with this newsletter), On August 2, 2019, the US government agency that administrates Medicare & Medicaid (CMS) announced several significant changes to hospital antibiotic reimbursement in US hospitals, effective October 1, 2019 (link to the very detailed Federal Register notice; go here for user-friendly summaries in Health

4 August 2019 No Comments

FDA Workshop: Animal models in support of narrow-spectrum agents for A. baumannii and P. aeruginosa

Dear All: FDA today hosted their eagerly awaited workshop on animal models in support of narrow-spectrum agents for A. baumannii (Abau) and P. aeruginosa (Pae). It was a really full & interesting day at the end of which my confidence that we can actually register narrow-spectrum agents for these two pathogens (and others that are even less frequent) is

1 March 2017 No Comments

FDA AMDAC – Developing Single-Pathogen agents for P. aeruginosa and A. baumannii

Dear All (and with apologies … long note alert!): Yesterday’s AMDAC was very productive. For reference, all the materials are here and a reasonably detailed set of notes are found below my signature. For further color, David Shlaes has also posted a summary on his Perfect Storm blog. FDA nicely positioned the question for the day as “It will

13 April 2017 No Comments

IDSA White Paper on developing narrow-spectrum antimicrobials + editorial by G. Drusano

Dear All (long note alert … there’s a lot of material below my signature): Just published today is an IDSA White Paper entitled “Developing Antimicrobial Drugs for Resistant Pathogens, Narrow-spectrum Indications, and Unmet Needs.” The paper is accompanied by an editorial by George Drusano. As the papers are free to download (links below). The white paper reviews the

5 May 2017 No Comments

AMR.Solutions

Wonkish

New mechanisms for antibiotic reimbursement in the United States: CMS’s IPPS FY2020 Final Rule

FDA Workshop: Animal models in support of narrow-spectrum agents for A. baumannii and P. aeruginosa

FDA AMDAC – Developing Single-Pathogen agents for P. aeruginosa and A. baumannii

IDSA White Paper on developing narrow-spectrum antimicrobials + editorial by G. Drusano

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