Aug 11, 2023
Europe
The new article highlights aspects related to electronic submissions and specific types of products. Table of Contents The Swiss regulatory authority in the sphere of healthcare products (Swissmedic) has published a guidance document dedicated to the regulatory...
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Aug 11, 2023
FDA
The new article provides additional information about the submission process depending on the submission type. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published an...
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Aug 11, 2023
FDA
The new article addresses the aspects related to the description of functionality and intended use to be included in the submission in the context of patient-matched guides. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
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Aug 10, 2023
FDA
The new article describes in detail the approach to be applied with respect to meetings under the Q-Submission program and also clarifies the way unique numbers are assigned to incoming requests in order to ensure traceability. Table of Contents The Food and Drug...
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Aug 10, 2023
Europe
The guidance addresses aspects related to the safety measures to be developed and introduced by the parties responsible for performance trials in order to ensure the safety of study participants while maintaining the accuracy and reliability of the study results....
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Aug 10, 2023
FDA
The new article highlights aspects related to the content of the submission in the context of patient-matched guides. 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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