FDA
The new article describes in detail specific technologies to be used for clinical trials with decentralized elements and also clarifies the roles and responsibilities of the parties involved.
FDA
The new article provides additional clarifications regarding the oversight to be conducted by the authority when it comes to clinical trials with decentralized elements, and also highlights specific aspects related to the administration of products subject to investigation.
FDA
The new article outlines certain specific aspects related to the existing legal framework, such as packaging, shipping, safety monitoring, as well as the use of electronic systems.
FDA
The new article emphasizes the important role of patient preference information.
FDA
The new article pays additional attention to the specific practical considerations pertaining to the use of patient preference information.
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