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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Dec 9, 2022
FDA
The new article highlights the aspects related to the measures intended to improve the accuracy of the study results and address potential bias. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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Dec 7, 2022
FDA
The new article highlights the key points related to the determination of a study and reporting status. 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 guidance...
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Dec 7, 2022
FDA
The new article highlights the key points related to study population and planning, selection of study participants (subjects), and specimen collection. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere...
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Dec 7, 2022
FDA
The new article addresses the aspects related to the evaluation of post-approval study reports. 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 guidance document...
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