Hogan Lovells Publications | Focus On Regulation | 08 February 2019
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On Tuesday, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance, "Principles of Premarket Pathways for Combination Products," with high-level information on ways to bring combination products to market.
Although the draft guidance doesn't break new ground, it provides some useful clarity; for example, it includes detailed illustrations of five circumstances when those pathways apply.
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