Submission order, identifiers and electronic signatures in pdfs are among the issues that the Health Sciences Authority is addressing as it prepares to implement the electronic common technical document format for dossier submissions this year.
Singapore’s Health Sciences Authority has provided an update on its planned implementation of the electronic common technical document (eCTD) format for dossier submissions and the key changes it is making following a consultation on the plan that received over 250 comments from 25 companies.
Companies using the eCTD format, which the HSA expects to introduce in Q4 2024, will no longer be prohibited from...
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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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