EU
The new article describes the way study benefits and objectives should be reflected in a clinical investigation plan.
EU
The new article provides additional clarifications regarding study design and data management aspects.
FDA
The new article outlines the general considerations associated with the Q-Submission Program to facilitate the process of obtaining feedback from the authority concerning regulatory submissions.
FDA
The new article provides a general overview of the Q-submission process as the relevant legislation prescribes.
FDA
The new article describes potential questions to be discussed with the authority in the context of the Q-Submission Program interactions.
FDA
The article provides an overview of the regulatory approach to be applied concerning certain regulatory matters.
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