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 26, 2023
FDA
The new article highlights the key points related to specific products eligible for the program, their periodic evaluation, and eligibility requests. Table of Contents The Food and Drug Administration (FDA or the Agency), has published a draft guidance document...
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Jan 16, 2023
FDA
The new article addresses the aspects related to the principles to be followed with respect to voluntary reporting, and also describes the approach the authority applies when determining the eligibility criteria to be considered. Table of Contents The Food and Drug...
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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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