Jun 30, 2023
FDA
The new article describes in detail the procedure to be followed when submitting a request under the Q-Submission framework. In particular, the authority pays attention to the content of submissions. Table of Contents The Food and Drug Administration (FDA or the...
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Jun 27, 2023
FDA
The new article provides an overview of the guidance document describing the approach to be applied with respect to information the authority expects to be included in submissions for a specific type of product. Table of Contents The Food and Drug Administration (FDA...
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Jun 26, 2023
FDA
The new article highlights the aspects related to how an applicant should submit requests for feedback and explains the approach to be applied with respect to combination products. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
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Jun 25, 2023
FDA
The article provides an overview of the questions and answers document issued by the US regulating authority and highlights the key points related to Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in healthcare...
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Jun 25, 2023
FDA
The new article highlights the aspects related to additional submission types that could be used in specific cases and also describes the approach to be applied when no relevant submission type is used. Table of Contents The Food and Drug Administration (FDA or the...
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