Business · 16/02/2018Updated: 10/17/2026 · 1 min read

FDA Announces Draft Guidance for Electronic Submission of Bioresearch Monitoring Inspection Planning for CDER Submissions

Summary

The FDA has released a draft guidance outlining standardized formats for electronic submission of data and information for bioresearch monitoring inspections, aiming to assist applicants in submitting electronic data for CDER submissions

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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