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ESG Chapter 6 References/Resources

ESG User Guide - Table of Contents

Chapter 6 References/Resources

6 References/Resources

The following table provides some additional references and resources related to electronic submissions and the FDA ESG.

Table 6: Additional References

Document Web Link

Electronic Regulatory Submissions and Review


FDA AERS Electronic Submissions Web Site


Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Safety Reports


Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format - Investigational New Drug Applications (INDs)


Updated Guidance for Industry: Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format -- General Considerations




ICH Home Page


PDUFA Main Page on FDA Site


PhRMA Home Page

http://www.phrma.org/ disclaimer icon

ESG ADI (Internal Users Only)

ADI Definitions.pdf 

FDA ESG ADI Dashboard Pocket Guide.pdf

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