I wrote on 19 Oct 2017 about the meeting on 7 Nov 2017 of the Vaccines and Related Biological Products Committee (VRBPAC) at White Oak to discuss Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations. I noted before, we've had prior debates on this topic that have revolved around these questions:
The FDA briefing book is excellent and I commend it to you ... it provides a good summary of past (failed) efforts in this area as well as further details on the key question to be discussed.
All best wishes, --jr
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: http://amr.solutions/blog-index.html
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