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In this section: Guidance for Industry

Electronic Submissions Guidances

CVM GFI #108 Registering with CVM’s Electronic Submission System
Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (PDF - 103KB)
CVM GFI #225 (VICH GL53) Electronic Exchange of Documents: File Format Recommendations
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Resources

Electronic Submissions

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