Jan 16, 2023
FDA
The new article outlines the key points of the newly issued guidance document addressing the matters related to malfunction reporting. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
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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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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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