Feb 7, 2023
Asia
The new article describes in detail the aspects related to registration that combination products should undergo in order to be allowed for marketing and use in the country. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the...
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Feb 7, 2023
FDA
The new article covers the matters related to antigen diagnostic tests and explains the approach to be applied by the test developers in order to ensure the continued effectiveness of their devices. Table Of Contents: The Food and Drug Administration (FDA or the...
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Feb 7, 2023
FDA
The new article highlights the key points related to molecular diagnostic tests and describes the recommendations provided by the authority in this respect. Table Of Contents The Food and Drug Administration (FDA or the Agency), the UA regulating authority in the...
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Feb 7, 2023
Asia
The article covers the general points related to the regulatory requirements for combination products. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulating authority in the sphere of healthcare products, has published the guidelines for...
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Feb 7, 2023
FDA
The new article highlights the aspects related to the way the impact of viral mutations can be addressed when developing tests. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...
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