Feb 9, 2023
FDA
The new article highlights the aspects related to the initial review of submissions, including the stages of the review process. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulatory agency in the sphere of healthcare products, has...
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Feb 9, 2023
FDA
The new article highlights the aspects related to certain specific cases when the review clock will stop due to the decisions taken by the authority. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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Feb 7, 2023
FDA
The article provides an overview of the regulatory requirements related to the actions to be taken by the authority and/or applicant in the context of premarket notification, and the effect such actions will have on the review timelines. Table Of Contents: The Food...
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Jan 23, 2023
Europe
The article highlights the key points related to the qualification of medical devices for the purpose of determination of their regulatory status, and also provides additional details regarding the most important concepts used. Table of Contents The UK Medicines &...
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Oct 20, 2022
Europe
The article provides an overview of the regulatory policy to be applied to software products and highlights the key points associated thereto. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority, has published...
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