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)
  • Send and Track Medical Device Premarket Submissions Online: CDRH Portal
  • 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