FDA
has issued a draft guidance relating to electronic submissions. Guidance for
Industry: Providing Submissions in Electronic Format—Summary Level Clinical
Site Data for CDER’s Inspection Planning is one in a series of guidance
documents intended to assist sponsors and applicants making certain regulatory
submissions to FDA in electronic format.
The
draft guidance describes FDA’s recommendation that applicants submit
summary-level clinical-site datasets in a standardized electronic format. This
guidance generally applies to submissions of summary-level clinical-site
datasets for new drug applications (NDAs), biologics licensing applications
(BLAs), and NDA and BLA supplemental applications containing new clinical-study
reports that are submitted to FDA’s Center for Drug Evaluation and Research
(CDER). The purpose of the guidance is to assist applicants in the submission
of a clinical dataset that describes and summarizes the characteristics and
outcomes of clinical investigations at the level of the individual study site
(summary-level clinical-site data). The summary-level clinical-site dataset is
intended to facilitate the use of a risk-based approach for the timely
identification of clinical investigator sites for on-site inspection by CDER
during the review of marketing applications. The guidance refers to a number of
technical specification documents and other resources. These technical
specification documents and resources are available online to make them more
accessible to applicants.
Posted by Tim Sandle
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