Quality & Compliance: Postmarket Safety Reports for Combination Products

| 01 January 2010

This is the sixth in a series of articles on the regulation of combination products by the US Food and Drug Administration (FDA). Currently there are no rules or guidance on submitting safety reports for combination products. This article considers how existing regulations for drugs, biological products and medical devices may be applied to postmarket safety reporting and looks at FDA's recently published proposed rule on this subject. Before the proposed rule, the only published agency commentary on postmarket safety reporting for combination products was a 2005 concept paper1 issued by the Office of Combination Products, which discussed options FDA was considering to address this "downstream issue."2 The proposed rule on postmarketing safety reporting for combination products3 provides insight into FDA's current thinking on requirements for the submission of postmarket safety reports. Rather than establishing a new safety reporting mechanism specific to combination products, the agency has chosen to build upon existing regulations. This article considers approaches to postmarket safety reporting that many combination product manufacturers are currently following and how these practices may need to change when a final rule is published and becomes an enforceable requirement. This article is neither a commentary on the proposed rule nor does it present a complete analysis of the rule.


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