Patient safety Archives

FDA Guidance on General Considerations for Animal Studies: Test System Monitoring

Dec 19, 2023

FDA

FDA Guidance on General Considerations for Animal Studies: Test System Monitoring

The new article highlights the aspects related to monitoring methods and associated matters.

HSA Draft Guidance on Clinical Evaluation: Data Sources

Nov 29, 2023

HSA

HSA Draft Guidance on Clinical Evaluation: Data Sources

The new article addresses the aspects related to the sources of data used in the context of clinical evaluation of medical devices.

HSA Draft Guidance on Clinical Evaluation: Definitions

Nov 22, 2023

HSA

HSA Draft Guidance on Clinical Evaluation: Definitions

The new article addresses the aspects related to the key concepts used in the context of clinical evaluation.

EDA Guidance on Reporting Adverse Reactions: Minimum Criteria

Nov 16, 2023

EDA

EDA Guidance on Reporting Adverse Reactions: Minimum Criteria

The new article addresses the aspects related to the minimum criteria an adverse reaction report should meet to comply with the respective requirements.

FDA Revised Guidance on MR Safety: Image Artifact and Reporting Results

Nov 16, 2023

FDA

FDA Revised Guidance on MR Safety: Image Artifact and Reporting Results

The article addresses the aspects related to possible image artifacts and the way they should be treated and also describes the approach to be applied when reporting results.

RegDesk Regulatory Roundup

FDA Guidance on General Considerations for Animal Studies: Test System Monitoring

HSA Draft Guidance on Clinical Evaluation: Data Sources

HSA Draft Guidance on Clinical Evaluation: Definitions

EDA Guidance on Reporting Adverse Reactions: Minimum Criteria

FDA Revised Guidance on MR Safety: Image Artifact and Reporting Results

Categories

Categories

Tags