Jan 27, 2023
FDA
The article provides an overview of the factors resulting in delaying or refusing 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Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance...
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Jan 27, 2023
FDA
The new article highlights the aspects related to limitations the authority may impose with respect to the application of the program for certain medical devices or scenarios. Table of Contents The Food and Drug Administration (FDA or the Agency), the US authority in...
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Jan 27, 2023
FDA
The new article addresses the aspects related to the scope of events eligible for the program, as well as to its general conditions. 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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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 Table of Contents The Food and Drug Administration (FDA or the Agency), has published a draft guidance document...
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