Originally Published MDDI March 2005
More Consistency Needed for Combination Product Regulation
FDA should apply a more consistent approach to reviewing combination products, said participants at a recent summit.
The Regulatory Affairs Professionals Society (RAPS; Rockville, MD) held a symposium on combination product regulatory issues, billed as the first of its kind, in January in Baltimore. Panelists and participants noted that combination products involve product classes regulated by three different FDA centers, each of which has a markedly different culture from the others. This means that FDA's expectations for a combination product application, and the standards to which it will be held, vary based on which center handles the review. Thus, they said, similar products can face very different regulatory outcomes.
At the heart of the recommendations is a call for FDA to modify its intercenter agreements. The revised agreements would more clearly delineate each center's roles and responsibilities for handling approvals of combination products, modifications to existing combination products, and labeling reviews. Another suggestion is to develop a common set of combination product terms and definitions to be used by all relevant industries and FDA centers.
Mark Kramer, director of FDA's Office of Combination Products, said the recommendations should be useful. “While we can't solve all of the issues addressed here overnight, your input will be very helpful to us,” he said.
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