Australia
The article highlights the critical points related to the regulatory status of certain software products.
Australia
The new article provides an in-depth overview of the problems identified and solutions proposed by the authority, together with the questions to be answered by the key stakeholders.
Australia and Oceania
The new article provides a brief overview of the regulatory approach towards software-based products intended to be marketed and used in Australia. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...
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...
Australia and Oceania
The present article provides a brief overview of the regulatory matters related to the clinical evaluation reports to be submitted by the parties responsible for clinical trials. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating...
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