HSA Draft Guidance on Clinical Evaluation: Overview
The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.
The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.
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 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...
The article highlights the aspects related to the rights and responsibilities of Institutional Review Boards in the context of informed consent. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere...
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...