BASG Notice on Drug-Device Combination Products
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 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.
The new article pays special attention to the prerequisites of a clinical trial, addressing the matters related to protocols and key elements thereof.
The new article outlines the key ethical and safety considerations pertaining to clinical studies.
The new article provides extensive clarifications regarding the responsibilities of study sponsors as the parties playing the key role in the investigation process.