Oct 16, 2023
FDA
The new article highlights the aspects related to design considerations including control mechanisms to be implemented. 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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Oct 13, 2023
FDA
The article highlights the key points related to the regulatory status of the products based on the existing legal framework. 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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Oct 13, 2023
FDA
The new article highlights the aspects related to design considerations in the part of risk management. The document also provides an overview of the most important terms and concepts used. Table of Contents The Food and Drug Administration (FDA or the Agency), the...
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Oct 13, 2023
FDA
The article highlights the key points related to the regulatory status of the products in question and describes the approach to be followed. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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Sep 28, 2023
FDA
The article highlights the aspects related to existing submission formats and key considerations associated thereto in the context of the Voluntary Improvement Program. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
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