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Additional References

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

DocumentWeb Link
Electronic Regulatory Submissions and Reviewhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM085361
FDA AERS Electronic Submissions Web Sitehttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm
Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Safety Reportshttp://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
Updated Guidance for Industry: Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format -- General Considerations

 

 

 

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