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Common Issues Found in Substantial Equivalence Reports

Common Issues Found in Substantial Equivalence Reports

To help companies prepare a substantial equivalence (SE) Report for submission and to avoid common deficiencies that may result in an unfavorable decision on an application, the FDA has posted appendices (organized by product type) containing common issues the agency has identified in previous SE Reports. To provide additional clarity, these appendices are also included with the acknowledgment and notification letters related to these SE Reports.

The information included in these appendices reflects deficiencies frequently seen in previous SE Reports that FDA has reviewed, organized by tobacco product


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