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Combination product jurisdiction

This article was originally published in The Gray Sheet

Executive Summary

FDA's 1991 Intercenter Agreements "should not be independently relied upon," although they "may still be helpful in certain situations," OCP advises in a FDL-1jurisdictional update posted on its website Sept. 6. The ICAs provided some guidance for how combination products would be regulated based on the "way the world was in 1991," OCP Director Mark Kramer said, but his office is working to create processes that are "more translatable to the future." OCP recently issued guidance on writing a request for center designation, incorporating the agency's primary mode of action 1final rule. It also posted two concept papers Sept. 6...

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