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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...

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