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 supplemental reports medical device manufacturers should submit and also provides an overview of the summary reporting instructions. 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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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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