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NIAID BAA To Support In Vitro Diagnostic Product Development

Dear All, Excitingly, NIAID has released a new BAA (Broad Agency Announcement) entitled “Diagnostics Pre-Clinical Services Program.” Similar to the prior BAA for support of biopharmaceutical product development, this new BAA for diagnostic devices seeks a group who can manage a “multiple award Indefinite Delivery/Indefinite Quantity (IDIQ) type contract” (read that slowly!) and through it offer a comprehensive

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20 April 2022 No Comments

FDA and EMA regulatory updates / Fireside chat during the 4th AMR Conference

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

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14 September 2020 No Comments

Ready, set, go! AMR appropriations in the US FY2025 budget

Dear All, If you follow US politics, you will know that the USG (US Government) is beginning its appropriations process for FY2025 (Federal Year 2025). In preparation, a letter calling for AMR-related funding has been drafted by the Infectious Diseases Society of America (IDSA), AdvaMedDx, American Society for Microbiology (ASM), Association for Professionals in Infection Control

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14 March 2024 No Comments

Call for Pull: Swiss Roundtable on Antibiotics

Dear All, To end the week, we have a really lovely paper from the Swiss Roundtable on Antibiotics (a multidisciplinary, non-profit Swiss association). Here are the links you need: The new (25 March 2024) paper entitled “Effective antibiotics for the Swiss health care system: today and in the future.” A prior (7 Feb 2023) paper

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5 April 2024 No Comments

EMA Concept Paper: Guidance on manufacturing of phage products

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

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28 January 2024 No Comments

A new BAA, now from FDA!

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

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9 October 2023 No Comments

Help PASTEUR cross the finish line: Action Alert from IDSA!

Dear All, Today’s news is that the House PASTEUR sponsors (Drew Ferguson [R-GA-3], Scott Peters [D-CA-50], Jake LaTurner [RKS-2] and Mike Levin [D-CA-49]) are urging House leadership to authorize the PASTEUR Act without initially having funding attached. Although this may seem counterintuitive, initial passage as a $0 bill is a solid strategy — it is common

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3 April 2024 No Comments
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