CDER Seeking Input on Study Data Template

Federal Register notice: CDER is seeking comments on a proposed “Analysis Data Reviewer’s Guide” (ADRG) template that was developed under an ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non-profit consortium addressing computational science issues. The template is under review to determine whether the Center will recommend its use either as is, or in a modified form, for study data regulatory submissions. Currently, a 2014 FDA Study Data Technical Conformance Guide contains technical recommendations to sponsors for submitting animal and human data and related information in a standardized electronic format. In section 2.3 of the guide, the agency recommends that sponsors include a plan describing the submission of standardized study data to FDA. CDER is now reviewing the ADRG template to determine whether to recommend its use in the regulatory submission of study data in conformance with the guide. To view the notice, click here.