Sentinel Research, Communication Transparency Needed, GSK’s Troy Urges
FDA needs a more open, transparent process for developing plans for drug safety studies in its Sentinel electronic data surveillance project as well as for announcing results, GlaxoSmithKline Senior VP and General Counsel Daniel Troy urged during a conference on Sentinel Jan. 12.
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
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