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...
FDA
The article covers additional questions industry representatives may have with respect to informed consent and specific aspects associated thereto. In particular, the aspects addressed include the involvement of children and non-English speakers. Table of Contents...
Asia
The article describes in detail the approach to be applied with respect to clinical evidence the parties responsible for medical devices are expected to provide when applying for marketing approval. Table of Contents The Health Sciences Authority (HSA), Singapore’s...
Canada
The article highlights the aspects related to the regulatory status of such categories as “medical device group”, “medical device group family” and “medical device system”. Table of Contents Health Canada, the Canadian regulating authority in the sphere of healthcare...
FDA
The article highlights the aspects related to existing submission formats and key considerations associated thereto in the context of the Voluntary Improvement Program. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
