FDA Taking Steps To Simplify Combo Product Consultations

The agency releases an internal assessment of how it handles inter-center 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 released by the agency Oct. 14.

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