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FDA Says It's Taking Steps To Simplify Combo Product Consultations

The agency released an internal assessment of how it handles intercenter consultations for combination products. As expected, there are some serious challenges to collaboration between the centers, but FDA says it is taking tangible steps to make it better.

FDA says it is already simplifying access to its IT system, revising SOPs, updating its organizational charts and putting out more guidance documents, as recommended in an internal assessment of its inter-center consultation process for combination products that was released by the agency Oct. 14.

The assessment, conducted by the agency's Office of Planning, was launched in 2014 in response to complaints from industry that the product centers within FDA were not effectively coordinating and communicating, leading to confusion and delays in the review of combination products. In the meantime, the number of intercenter consultations has skyrocketed in recent years (see graph below), a significant portion of which are initiated as questions by drug center reviewers to the device center about device human factors issues

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