Skip Navigation
FDA Logo U.S. Food and Drug Administration U.S. Department of Health and Human Services

FDA ELECTRONIC SUBMISSIONS GATEWAY (ESG)



Submission Types Accepted by FDA Centers

Center Submissions
  CBER  

AERS - Adverse Event Reports

AERS Attachments

BLA - Biologics License Application (eCTD and eBLA format)

eCTD - Electronic Common Technical Document

IDE - Device Exemption

IND - Investigational New Drug Application (eCTD and eIND format)

DMF - Drug Master File

Promotional Materials











  CDER  

AERS - Adverse Event Reports

AERS Attachments

ANDA - Abbreviated New Drug Application

BLA - Biologics License Application (eCTD and eBLA format)

eCTD - Electronic Common Technical Document

NDA - New Drug Application (eCTD and eNDA format)

IND - Investigational New Drug Application











  CDRH  

Adverse Events

Electronic Submissions











  CVM  

Electronic Submissions



FDA Industry Systems Website Staff
August 18, 2006