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306 result(s) found, displaying 1 to 10
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Summary report of residual DNA and endotoxin on CoVID-19 mRNA vaccines conducted by TGA Laboratories
TGA laboratory testing reportsThe TGA has conducted a comprehensive evaluation of the residual DNA and endotoxin levels in the two mRNA vaccines supplied in Australia - Comirnaty (Pfizer) and Spikevax (Moderna). -
PageCOVID-19 vaccine batch release information is now available
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Media releasesWe are aware of misinformation that claims the COVID-19 mRNA vaccines are contaminated with excessive levels of DNA. This is not the case.
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GuidanceGuidance relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.
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GuidanceGuidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen tests.
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GuidanceGuidance clarifying the interaction between our requirements and AHPRA advertising guidelines.
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GuidanceInformation on the rules governing COVID-19 rapid antigen tests (RATs) advertising.
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GuidanceInformation to assist sponsors and manufacturers of products making antiviral claims determine if their product require an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.
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GuidanceGuidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
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GuidanceGuidance for new sponsors on how to supply, import, and export disinfectant products.
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