Swissmedic
The article highlights the key points related to the regulatory requirements for combination studies intended to be carried out in Switzerland.
Swissmedic
The new article provides further clarifications regarding the authorisation procedure to be followed by the parties interested in conducting combination studies in Switzerland.
Swissmedic
The new article clarifies the approach to be followed when introducing modifications to combination studies already approved by Swissmedic.
Swissmedic
The new article outlines the reporting requirements to be followed by the parties responsible for clinical investigations conducted in Switzerland.
FDA
The document highlights the key points related to the requests for information to be submitted under the existing legal framework.
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