Links to Center-Specific Submission Preparation Guidelines

• Center for Biologics Evaluation and Research (CBER)
  Regulatory Submissions in Electronic Format for Biologic Products
  Providing Regulatory Submissions to CBER in Electronic Format - Lot Release Protocols
  Vaccine Adverse Event Reporting System (VAERS) Electronic Submissions
  Guidance on Transmitting Electronic Submissions Using eCTD Specifications
• Center for Drug Evaluation and Research (CDER)
  Electronic Regulatory Submission and Review
  Affordable Care Act (ACA 6004) submission guidelines
  Guidance on Transmitting Electronic Submissions Using eCTD Specifications
• Center for Devices and Radiological Health (CDRH)
  eMDR - electronic Medical Device Reporting
  FDA eSubmitter tool
  GUDID – Global Device Identification Database
  
• FDA Adverse Event Reporting System (FAERS)
  FDA Adverse Events Reporting System (FAERS) Electronic Submissions
• Center for Veterinary Medicine (CVM)
  Guidelines for Electronic Submissions
• Office of the Commissioner (OC)
  Structured Product Labeling Resources
  Electronic Drug Registration and Listing Instructions
• Center for Tobacco Products (CTP)
  FDA eSubmitter tool
  Tobacco Guidance, Compliance & Regulatory Information
• Center for Food Safety and Nutrition (CFSAN)
  Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety

For information on tracking submissions, please refer to the Tracking Submissions section of the ESG User’s Guide.