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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Nov 4, 2022
FDA
The new article highlights the key points to be taken into consideration with respect to endpoints in clinical studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
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Nov 4, 2022
FDA
The new article highlights the main points related to the assessment of applicable risk, as well as the concept of direct benefit for study participants. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere...
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