Sep 27, 2023
FDA
The article addresses the aspects related to the responsibilities of the parties involved in clinical investigations, namely, study sponsors and clinical investigators. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
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Sep 26, 2023
FDA
The new article highlights aspects related to the role and responsibilities of the US regulatory authority with respect to informed consent to be obtained before commencing clinical investigations involving human subjects. Table of Contents The Food and Drug...
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Sep 26, 2023
FDA
The new article describes in detail the approach to be applied with respect to documentation related to informed consent. 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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Sep 22, 2023
FDA
The new article describes in detail the approach to be applied with respect to general operating systems and drivers used in medical devices, as well as safety measures to be taken into consideration when medical devices are intended to be connected to any network....
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Sep 22, 2023
FDA
The new article covers aspects related to additional elements of informed consent to be included where necessary. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published...
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