Nov 17, 2022
FDA
The new article highlights the key points to be considered for the placebo effect in the context of clinical investigations and also outlines the measures to be taken to mitigate this effect and its impact on the study results and data collected in the course of a...
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Nov 10, 2022
FDA
The new article highlights the key points related to study procedures in pediatric clinical investigations, and also provides a summary of the key points addressed in the guidance. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
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Nov 10, 2022
FDA
The new article highlights the key points related to the controls in comparative clinical outcome studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a...
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Nov 10, 2022
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the ethical considerations for clinical investigations with children involved. By virtue of the...
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Nov 10, 2022
FDA
The new article provides additional information regarding the intervention assignment (randomization) for clinical outcome studies and blinding (masking). Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere...
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Nov 4, 2022
FDA
The new article provides additional details regarding the parental/guardian permission to be obtained before commencing an investigation, and also regarding the supporting data a study sponsor shall provide. Table of Contents The Food and Drug Administration (FDA or...
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