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Postmarketing Safety Reporting for Combination Products (Final Rule)

Postmarketing Safety Reporting for Combination Products (Final Rule)

The Food and Drug Administration (FDA) is issuing a final rule to establish postmarketing safety reporting requirements for combination products. In particular, the final rule explains which postmarketing safety reporting requirements apply depending on a product’s application type under which the combination product or constituent part received marketing authorization. The final rule also requires the submission of additional specified reports, based on the constituent parts included in the combination product. Finally, the final rule requires that constituent part applicants share certain postmarketing safety information with each other.

Regulatory Impact Analysis

Postmarketing Safety Reporting for Combination Products (Final Rule) RIA (PDF - 132KB)

Federal Register: 81 FR 92603, December 20, 2016

Docket: FDA-2008-N-0424