FDA Seeks Public Comment on PhUSE SDSP Template

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The Food and Drug Administration (FDA) publishes intent to review the PhUSE SDSP for regulatory submissions, developed by PhUSE Computational Science Working Groups.

PhUSE CSS 2017

PhUSE CSS 2017

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is establishing a public docket to collect comments related to a proposed Study Data Standardization Plan (SDSP) template. As part of the FDA’s on going collaboration with PhUSE, an independent, non-profit consortium addressing computational science issues, the SDSP template was developed by a PhUSE computational science working group.

The purpose of the review is to evaluate the template and determine whether the FDA will recommend its use, either as it is, or in a modified form, for regulatory submissions of study data. The FDA invites public comment on all aspects of the SDSP template. To ensure all comments are considered as part of the review, they should be submitted before 9th January 2017.

The FDA is a participating member of PhUSE. As part of this collaboration, PhUSE Working Groups develop and periodically publish proposals for enhancing the review and analysis of human and animal study data submitted to regulatory agencies. To find out more about PhUSE CS Working Groups visit http://www.phuse.eu/cs-working-groups.aspx.

The CS Working Groups meet annually at the PhUSE Computational Science Symposium (CSS) in Silver Spring, MA. The 6th annual CSS, to be held 19th to 21st March 2017, will once again bring together FDA, PhUSE and industry in this unique collaborative event, to address computational science needs in support of regulatory review and ultimately bring safe and effective products to those who need them. This work will continue, later in the year, at the PhUSE European CSS to be held in London from 19th to 20th June 2017. Previous work has included the creation of a Nonclinical Study Data Reviewer’s Guide Template and the formation of a Statistical Computing Environment project to align industry requirements. Learn more about the CSS conferences at http://www.phuse.eu/CSS.aspx.

About PhUSE

PhUSE is a non-profit, volunteer-supported community of professionals, passionate about the advancement of clinical data science. It provides the industry with the premier platform for creating and sharing ideas, tools and standards around data and statistical reporting technologies. Since its inception, PhUSE has expanded from a single conference for European Statistical Programmers to a global platform for the discussion of topics encompassing the work of data managers, biostatisticians, statistical programmers and clinical data scientists.

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Sascha Ahrweiler
PhUSE
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