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...
The article provides an overview of the new classification approach adopted in Australia with respect to implantable medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian healthcare product regulatory authority, has...
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...
The new article explains the three steps testing approaches and highlights the key points associated thereto. The document also addresses the aspects related to documentation and reporting. Table of Contents The Pharmacy and...
The new article provides additional clarifications regarding certain specific aspects related to post-market surveillance, including the activities to be undertaken by the parties involved to ensure continuous safety and proper performance of medical devices placed on...