FDA publishes new guidance for the premarket review of combination products

The US Federal Food and Drug Administration (FDA) have published draft guidance on the principles of premarket guidance for combination products. Combination products could include components of drugs, biologic or device products.

In launching this guidance, FDA Commissioner Dr Scott Gottlieb said:

“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.”

During the launch, the Commissioner used the example of a sensor enabled pill/patch product as an example of a combination product which this guidance will address.

This news follows continued digital technology trends in announcements from the UK Secretary of State for Health and Social Care, Matt Hancock.

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Published on 13. February 2019 in News, News International