FDA Draft Guidance on Real-World Evidence: Considerations for Collection and Analysis
The article highlights the aspects related to the key considerations for methodologies used in the context of the collection and analysis of real-world evidence.
The article highlights the aspects related to the key considerations for methodologies used in the context of the collection and analysis of real-world evidence.
The article highlights the aspects related to data evaluation, appraisal, and also to the reports to be prepared by the parties responsible for clinical evaluation.
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...
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...
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...