FDA Draft Guidance on Patient Preference Information in the TPLC: FDA Feedback
The new article highlights the aspects related to obtaining feedback from the authority in order to ensure compliance with the relevant regulatory requirements.
The new article highlights the aspects related to obtaining feedback from the authority in order to ensure compliance with the relevant regulatory requirements.
The new article is dedicated to additional considerations to be taken into account when using patient preference information associated with medical devices intended to be marketed and used in the US.
The new article highlights the key points related to the actual implementation of the information collected from patients in the form of feedback.
The article provides a general overview of the regulatory framework for combination products applicable in the EU in general and in Austria specifically.
The article highlights the key points related to clinical trials and the way they should be conducted in order to ensure the accuracy and reliability of the results, as well as the safety of the patients involved.
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