Feb 23, 2023
FDA
The document outlines the key points related to the Maltese regulatory requirements in the sphere of medical devices. In particular, the guidance addresses the matters associated with the fees payable by the parties responsible for medical devices intended to be...
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Feb 17, 2023
FDA
The new article describes in detail the aspects related to the measurements to be performed in the course of clinical investigations for neonatal products, including the duration and timing. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the...
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Feb 17, 2023
FDA
The new article highlights the aspects related to the key considerations related to the study design. 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...
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Feb 14, 2023
FDA
The new article highlights the questions related to the impact of the actions committed by the applicant on the FDA review clock. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has...
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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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