For Industry
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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
Affordable Care Act (ACA 6004) submission guidelines - 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 - 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.
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