Content of Integrated Summaries of Efficacy and Safety (ISE/ISS): A Blog Series
We are pleased to bring you a new series on the Content of the Integrated Summaries of Efficacy and Safety.
This blog series on the Content of ISE/ISS focuses on the structure of the common technical document (CTD) and the objectives of the ISE/ISS. These articles outline what elements are required and the specific requirements in FDA submissions.
Introduction to the Integrated Summaries of Efficacy and Safety (ISE/ISS)
When sponsors prepare an application for the registration of pharmaceuticals for human use, a common technical document (CTD), with organization and content driven by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines, must be submitted to the regulatory authorities to facilitate the review process. This article focuses on the structure of the common CTD and the objectives of the ISE/ISS.
Content of the Integrated Summaries of Efficacy and Safety (ISE/ISS)
The Integrated Summaries of Efficacy (Effectiveness) and Safety (ISE/ISS) are highly technical documents included in the common technical document (CTD) which sponsors must submit to regulatory authorities as part of the application for the registration of pharmaceuticals for human use. This article focuses on what elements are required in the ISE/ISS to ensure a successful submission.
Specific Requirements for Integrated Summaries of Efficacy and Safety(ISE/ISS) in FDA Submissions
This article focuses on specific requirements for ISE/ISS FDA submissions and other specific requirements.
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