Jan 27, 2023
FDA
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...
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Jan 27, 2023
FDA
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...
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Jan 27, 2023
FDA
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...
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Jan 27, 2023
FDA
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...
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Dec 19, 2022
FDA
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...
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Dec 9, 2022
FDA
The new article highlights the key points related to potential failure of a responsible party to comply with a requirement to conduct a post-approval study, and also to the situations when information about post-approval studies is being disclosed. Table of Contents...
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