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308 result(s) found, displaying 11 to 20
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GuidanceGuidance clarifying the interaction between our requirements and AHPRA advertising guidelines.
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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). -
GuidanceGuidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
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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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Reference materialHow to apply for inclusion of face masks (including respirators), that are medical devices, in the Australian Register of Therapeutic Goods (ARTG).
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Reference materialInformation to help healthcare organisations update their operating procedures.
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Reference materialAnswers to frequently asked questions in relation to rapid antigen point-of-care tests.
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Reference materialBatch release testing of biological medicines (excluding vaccines) is no longer required.
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Reference materialTo enable timely distribution of COVID-19 treatments, international labels may be used during initial supply in Australia.
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Reference materialFrequently asked questions added