Jan 27, 2023
FDA
The new article describes in detail the approach to be applied with respect to an investigation plan and also provides definitions of the most important terms and concepts used in the context of the guidance. Table of Contents The Food and Drug Administration (FDA or...
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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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