Aug 14, 2023
FDA
The new article provides an overview of a guidance document issued by the US regulatory authority and highlights the key points to be taken into consideration by interested parties with respect to the existing legal framework. Table of Contents The Food and Drug...
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Aug 14, 2023
FDA
The new article addresses matters related to clinical performance testing, labeling, and modifications. For each of the aspects, the document provides additional clarifications, highlighting the key points to be taken into consideration in order to ensure compliance...
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Aug 14, 2023
FDA
The new article addresses aspects related to some specific types of requests, and also provides a checklist to be used by the authority when assessing the requests for feedback. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
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Aug 12, 2023
FDA
The new article addresses aspects related to non-clinical performance testing for patient-matched guides. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulatory authority in the sphere of healthcare products, has published a guidance...
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Aug 12, 2023
FDA
The new article addresses aspects related to submission issue requests as a specific type of submission under the Q-Submission program. 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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