Dear All: OK, I’ll say that I’m sending this around because the title was so intriguing and reminded me of the debates we’ve had about why fever is not part of endpoint definition for clinical trials of new drugs. But, this article (see weblink & abstract below) is an excellent, in-depth survey of how salicylic acid and
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
Dear All: I listened with interest to the 19 July 2017 FDA Workshop entitled “Development of New Tuberculosis Treatment Regimens– Scientific and Clinical Trial Design Considerations.” Most of the materials from the meeting are available online (see link below my signature). I was interested in this workshop both because I want to see new TB
Dear All: Among various paradoxes that surround antibiotic development, the challenge for health technology assessment (HTA) is often implied but to my knowledge has as yet only infrequently been formally discussed. As one step towards filling this gap, the London-based Office of Health Economics (OHE) released a paper a few days ago that provides a detailed
Dear All: After a multi-year gestation period (my notes on this project go back to 2012!!), a comment on the FDA draft HABP/VABP guidance document has now been submitted by the FNIH (Foundation for the NIH) Biomarkers Consortium HABP/VABP Project Team and posted online. Links to the docket and document are below my signature. The
I am pleased to say that a commentary to the G20 on behalf of the DRIVE-AB Steering Committee has now gone live in the Online First section of Lancet Infectious Diseases. The article is not Open Access so you’ll have to download it for yourself (link below). The commentary summarises some of DRIVE-AB’s preliminary findings
Dear All: FDA’s approval of delafloxacin (BAXDELA) was announced on 20 June 2017 and the label can be found here. In brief, delafloxacin is a fluoroquinolone with coverage for MRSA as well as key Gram-negative pathogens. The label is attached is worth reading as a good example of a modern label – reading closely will give