GSK’s Bird Flu Vaccine Approval May Hinge On Pandemic Postmarketing Study
This article was originally published in The Pink Sheet Daily
FDA will ask its Vaccines and Related Biological Products Advisory Committee to talk about how to verify and describe the clinical benefit of the vaccine under the accelerated approval regulations.
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Cell-based seasonal influenza vaccine needs both additional safety data in general and considerably more efficacy data in older patients, FDA advisory panel says.