R&D Insight

Final FDA LPAD guidance: Same substance, useful clarifications

Dear All, FDA have released the final version of their LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs, really should be LPPAAAD) guidance. You can get it here. I have generated a comparison with the Jul 2018 draft version that you can get here. As a reminder, the central concept of the LPPAAAD pathway

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Chemicals vs. drugs (Part 3): XKCD has the final word

Dear All, As a coda to the two newsletters on Chemicals, Drugs, and Halicin (link and link), XKCD gets the final word: Image reproduced with permission from https://xkcd.com/1217/. And, you might want to review XKCD on the importance of good apple stewardship (link). With thanks to Natalie Ma for sharing this, All best wishes, –jr

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Chemical vs. drugs (Part 2): How do you discriminate? / More on halicin

Dear All (wonkish note alert!), The recent newsletter on chemicals, drugs, and halicin (link, see also a follow-up newsletter here) generated significant discussion and new insights that I thought I would share in a follow-up newsletter. Our theme in Part 2 is “Trust, but verify!”  Let’s start by considering comments on the newsletter. A number of

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Chemicals vs. drugs (Part 1): The end of bacitracin / the buzz around halicin

This newsletter has a follow-up here. Dear All, Today’s theme is a 2-part journey that could be subtitled “Many are called, but few are chosen,” or “It’s easy to kill bacteria — steam, fire, and bleach are consistently effective — but those aren’t drugs!” Our first stop is with a very old compound, bacitracin. Approved in 1948

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Language matters: CRE vs. CPE; SDD vs. I; and MDR, XDR, PDR, UDR vs. DTR

Note: See also these related newsletters: 13 Jan 2019 (link) on DTR as part of the language of resistance and 7 June 2020 (link) on using DTR to estimate antibiotic value. Dear All (wonk-ish note alert!), Three technical points for your consideration today. All focus on the subtleties of language, something I always find fascinating

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