Sep 22, 2023
FDA
The new article addresses the FDA aspects related to the way information about risks and benefits associated with a clinical investigation should be communicated by a study sponsor to potential study participants. Table of Contents The United States Food and...
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Sep 21, 2023
FDA
The new article describes in detail the general requirements by FDA for informed consent to be followed by study sponsors and other parties involved in clinical investigations. Table of Contents The United States Food and Drug Administration (USFDA), the US...
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Mar 23, 2023
Asia
The new article highlights the aspects related to the recalls and withdrawals initiated by the authority or by a party responsible for a medical device itself. Table of Contents The Turkish regulating authority in the sphere of healthcare products has recently...
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Mar 6, 2023
Asia
The article provides an overview of the regulatory requirements related to recalls and withdrawals for general and in vitro diagnostic medical devices allowed to be marketed and used in Turkey. Table of Contents The Turkish regulatory agency in the...
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Feb 17, 2023
Asia
The new article covers the aspects related to the application of the reliance approach to specific categories of healthcare products and also provides an overview of the reliance procedures. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a...
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