ESG Chapter 6 References/Resources

Chapter 6 References/Resources

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

Document	Web Link
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: 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
Updated Guidance for Industry: Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format -- General Considerations	http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/RegulatorySubmissions/default.htm
ICH Home Page	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/
ESG ADI (Internal Users Only)	ADI Definitions.pdf FDA ESG ADI Dashboard Pocket Guide.pdf