Nov 17, 2022
Australia and Oceania
The new article highlights the key points related to clinical outcome studies that are not using concurrent (or historical) controls. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
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Nov 10, 2022
Australia and Oceania
The new article describes in detail the aspects related to the clinical evidence required for meshes, patches, and tissue adhesives. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products,...
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Nov 10, 2022
Australia and Oceania
The new article highlights the key points related to the clinical evidence for heart valve replacements using a prosthetic valve. Table of Contents The Therapeutic Good Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has...
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Nov 4, 2022
Australia and Oceania
The article describes in detail the approach to be applied for clinical evidence for implantable pulse generator systems and also highlights the key points to be considered in this respect, including the matters related to the scope of evidence to be provided. Table...
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Nov 3, 2022
Australia and Oceania
The new article describes in detail specific aspects related to the regulatory requirements for clinical evidence for cardiovascular devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
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