FDA is Seeking Public Comment on PhUSE Nonclinical SDRG Template

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The Food and Drug Administration (FDA) publishes intent to review the PhUSE Nonclinical SDRG for regulatory submissions, which has been developed by PhUSE Computational Sciences working groups.

PhUSE FDA Computational Science Symposium

PhUSE FDA Computational Science Symposium

meeting, collaborating and delivering valuable outputs

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 Nonclinical Study Data Reviewer's Guide (SDRG) template. As part of FDA's ongoing collaboration with PhUSE, an independent, non-profit consortium addressing computational science issues, a PhUSE Computational Science working group developed the PhUSE Nonclinical SRDG template.

FDA now intends to review the PhUSE Nonclinical SDRG template, with the potential result that FDA could recommend the use of the template in its current form, or in a modified form, for use in the regulatory submission of study data in conformance with the Guide. FDA invites public comment on all matters regarding the use of the PhUSE Nonclinical SDRG template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of nonclinical study data. FDA is seeking public comment on the use of the PhUSE Nonclinical SDRG template for regulatory submissions.

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. You can learn more about PhUSE CS working groups at http://www.phuse.eu/cs-working-groups.aspx.

The PhUSE CS working groups meet annually at the Computational Science Symposium (CSS) in Silver Spring, MA. The 5th annual CSS (March 13th to 15th 2016) will again bring together FDA, PhUSE and Industry in a collaborative event to address computational science needs in support of regulatory review and ultimately bring safe and effective products to those who need them. Previous work has included the creation of a Study Data Reviewer's Guide Template for submission, development of a study data standardisation plan referenced in the recent guidance and the forming of a Statistical Computing Environment project to align industry requirements. You can learn more about the CSS conference at http://www.phuse.eu/css.aspx

About PhUSE
PhUSE, Share – Contribute – Advance, provides the industry with the premier platform for creating and sharing ideas, tools and standards around data, statistical and reporting technologies; PhUSE is a non-profit, volunteer-supported, community of professionals who are passionate about advancement of clinical data science. Since its inception, PhUSE has expanded from its roots as a 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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