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
• Center for Drug Evaluation and Research (CDER)
  Electronic Regulatory Submission and Review
• Center for Devices and Radiological Health (CDRH)
  eMDR - electronic Medical Device Reporting
  FDA eSubmitter tool
• Adverse Event Reporting System (AERS)
  Adverse Events Reporting System (AERS) 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