GlaxoSmithKline's vaccine has 97.16% efficacy, surpassing Merck's Zostavax, but US advisory committee will weigh risks from inflammation which could cause ocular adverse effects and gout.
GlaxoSmithKline Biologicals SA's shingles vaccine Shingrix appears on track for a positive review by a US FDA advisory panel as potential safety concerns are to be addressed in the company's pharmacovigilance plan.
FDA's briefing document for the Sept. 13 meeting of the Vaccines and Related Biological Products Advisory Committee notes...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
