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

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