Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.
In the latest move to advance regulatory reliance in Brazil, the country’s medicines regulator, Anvisa, has approved new guidance setting out criteria for making use of pre- and post-market drug evaluations carried out by the foreign authorities it deems to be “equivalent” regulatory bodies.
The guidance, published this week, relates to registration and post registration studies of medicines, vaccines and biological products. It establishes...
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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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