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Bioresearch Monitoring Technical Conformance Guide

This document, issued by the U.S. Food and Drug Administration (FDA), outlines the technical specifications and recommendations for submitting bioresearch monitoring data. It serves as a guide for preparing and submitting essential clinical study information in electronic formats for New Drug Applications (NDAs) and Biologics License Applications (BLAs).

The guide details requirements for Clinical Study-Level Information, Subject-Level Data Line Listings by Clinical Site, and Summary-Level Clinical Site Datasets. These submissions are crucial for the FDA's Center for Drug Evaluation and Research (CDER) in planning Bioresearch Monitoring (BIMO) inspections.

For inquiries regarding this technical specifications document, contact CDER-BIMO-NDA-BLA-request@fda.hhs.gov.

For the most current version of this guide and related information, please visit the FDA's official website.

File Info : application/pdf, 26 Pages, 557.63KB

Final08112022- V3-Conformance-Guide-Submission-of-NDA-BLA-Content-for-BIMO

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