North America Archives

Nov 4, 2022

FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Parental Permission and Supporting Data

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...

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Endpoints

Nov 4, 2022

FDA

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Endpoints

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...

FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Direct Benefit

Nov 4, 2022

FDA

FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Direct Benefit

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...

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Stratification and Site Selection

Nov 4, 2022

FDA

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Stratification and Site Selection

The new article covers the aspects related to stratification for subject selection, as well as to site selection in the context of pivotal clinical investigations. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...

FDA Guidance on Ethical Considerations for Clinical Investigations with Children Involved: Principles and Risk Categories

Nov 3, 2022

FDA

FDA Guidance on Ethical Considerations for Clinical Investigations with Children Involved: Principles and Risk Categories

The new article describes in detail the principle of necessity and the way it should be applied. The article also covers the aspects related to risk categories for interventions or procedures without a prospect of direct benefit. Table of Contents The Food and Drug...

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Study Objectives and Selection

Nov 3, 2022

FDA

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Study Objectives and Selection

The new article highlights the key points related to the study objectives and subject selection in the context of pivotal clinical investigations. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...

RegDesk Regulatory Roundup

FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Parental Permission and Supporting Data

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Endpoints

FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Direct Benefit

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Stratification and Site Selection

FDA Guidance on Ethical Considerations for Clinical Investigations with Children Involved: Principles and Risk Categories

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Study Objectives and Selection

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