The International Conference of Harmonisation has at last finalized its organizational reforms that are expected to encourage the group's expansion beyond its current membership of regulators from five regions (Canada, the EU, Japan, Switzerland and the US) and three research-based pharmaceutical industry associations (from the EU, Japan and the US)1.
The International Conference of Harmonisation has at last finalized its organizational reforms that are expected to encourage the group's expansion beyond its current membership of regulators from five regions (Canada, the EU, Japan, Switzerland and the US) and three research-based pharmaceutical industry associations (from the EU, Japan and the US)1.
As reported previously in Scrip Regulatory Affairs, the new organization will still be known as ICH. However, this will stand...
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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.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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