Sep 29, 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 29, 2023
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...
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Sep 28, 2023
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...
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Sep 27, 2023
FDA
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...
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Sep 27, 2023
FDA
The article provides a general overview of the guidance document dedicated to the approach the US regulating authority intends to apply in order to facilitate medical device improvement while ensuring compliance with the applicable regulatory requirements. Table of...
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