Additional References
The following table provides some additional references and resources related to electronic submissions and the FDA ESG NextGen.
| 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 |
|
| 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/ --]){kind=small} |