Would you like an extra application with that? FDA mulls requiring dual applications for combination products

On Tuesday, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance, "Principles of Premarket Pathways for Combination Products," with high-level information on ways to bring combination products to market.

Although the draft guidance doesn't break new ground, it provides some useful clarity; for example, it includes detailed illustrations of five circumstances when those pathways apply.

Read More: Would you like an extra application with that? FDA mulls requiring dual applications for combination products


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