Released yesterday, the document outlines FDA’s preference toward single applications for combination products. The FDA released new draft guidance yesterday regarding premarket review for combination products those with a mix of components that span across the agencys drug, biologic and device product categories.The proposed premarket guidance, which may still be adjusted based on public feedback, broadly advises industry to submit a single regulatory application within the pathway that most closely aligns with that products primary mode of action, as opposed to submitting multiple types of applications. The draft also includes suggestions and examples of which kinds of products would be most appropriate for each regulatory center.Today, as part of several steps we’re taking in this area, we’re announcing a framework designed to enhance clarity, predictability, efficiency and consistency of premarket review for combination products, FDA Commissioner Dr. Scott Gottlieb said in a statement announcing the draft guidance. This framework will help ensure that the FDA coordinates effectively around the premarket review of these products. Among other steps, we’re clarifying what pathways to approval are available depending on whether a combination product is drug-led, biologic-led or device-led. We’re seeking feedback on this proposed approach and we’ll also be publishing additional guidance on specific premarket considerations for combination products to ensure efficient product development.

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