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ESG Chapter 6 References/Resources

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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

CBER Annual Report

http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122930.htm

Electronic Regulatory Submissions and Review

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
FormsSubmissionRequirements/ElectronicSubmissions/UCM085361

FDA AERS Electronic Submissions Web Site

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Surveillance/AdverseDrugEffects/ucm115894.htm

Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM072322.pdf

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

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM072369.pdf

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

http://www.fda.gov/downloads/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/General/UCM150028.pdf

Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm124751.pdf

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

 

 

 

ICH Home Page

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

PDUFA Main Page on FDA Site

http://www.fda.gov/oc/pdufa/default.htm

PhRMA Home Page

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

 

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