North America Archives

Jan 27, 2023

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Investigation Plan and Definitions

The new article describes in detail the approach to be applied with respect to an investigation plan and also provides definitions of the most important terms and concepts used in the context of the guidance. Table of Contents The Food and Drug Administration (FDA or...

FDA Guidance on Sustaining the Quality of Clinical Studies: Study Analysis and Changes to Pivotal Studies

Jan 27, 2023

FDA

FDA Guidance on Sustaining the Quality of Clinical Studies: Study Analysis and Changes to Pivotal Studies

The new article addresses the aspects related to the way study results should be analyzed, and also the ones related to changes made by a study sponsor to a pre-defined study design after the study itself has commenced. Table of Contents The Food and Drug...

FDA Draft Guidance on Denying or Limiting an Inspection

Jan 27, 2023

FDA

FDA Draft Guidance on Denying or Limiting an Inspection

The new article highlights the aspects related to behaviors considered denying or limiting an inspection. 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 draft...

FDA Guidance on Sustaining the Quality of Clinical Studies: Study Conduct

Jan 27, 2023

FDA

FDA Guidance on Sustaining the Quality of Clinical Studies: Study Conduct

The new article highlights the key points to be considered when conducting a study in order to sustain its quality, as well as to ensure the accuracy and reliability of its result. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...

FDA Draft Guidance on Human Factors Information: Risk-Based Approach

Jan 27, 2023

FDA

FDA Draft Guidance on Human Factors Information: Risk-Based Approach

The new article addresses the aspects related to the risk-based approach to human factors engineering information in marketing submissions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Sustaining the Quality of Clinical Studies

Dec 19, 2022

FDA

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Sustaining the Quality of Clinical Studies

The new article describes how clinical data should be handled and highlights the key points to be considered in this respect. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...

RegDesk Regulatory Roundup

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Investigation Plan and Definitions

FDA Guidance on Sustaining the Quality of Clinical Studies: Study Analysis and Changes to Pivotal Studies

FDA Draft Guidance on Denying or Limiting an Inspection

FDA Guidance on Sustaining the Quality of Clinical Studies: Study Conduct

FDA Draft Guidance on Human Factors Information: Risk-Based Approach

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Sustaining the Quality of Clinical Studies

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