Thursday, September 19, 2019

Thursday, September 19, 2019

Feedback flowing in to FDA following draft policy document publication


Feedback is continuing to flow in the FDA following the publication of a draft policy document on the future of combination products.

Combination products are those that have a mix of components that can be reviewed in the three FDA categories, devices, biologic, and drugs. It is predicted that technology will drive development of many more of these types of products in the future.

The FDA has sent out a call for feedback on the policy document, which has faced some criticism for its lack of clarity.

"This is a very important area of work and we look forward to sharing our perspective directly with the FDA," Emily Fox, communications manager for Proteus Digital Health, told FDA Reporter. The company was named checked in the FDA's draft guidance document.

The FDA approved Proteus Digital Health combination sensor-enabled pill, patch and drug product.

Some concerns have been raised over the lack of clarity in the draft guidance document.

It did not include any clear examples of or scenarios related to digital health products, Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in FDA law, told MobiHealth News.

“It doesn't really contribute clarity with regard to digital health in particular,” Thompson told the news site. “It basically is suggesting … that the agency is predisposed to believe that one regulatory submission will be appropriate for digital health combination products.”

On the publication of the draft policy, FDA Commissioner Scott Gottlieb promised it was aimed at enhancing "clarity, predictability, efficiency and consistency of premarket review for combination products.”

He added, "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.”

The general advice is that any pre-market review application would align with its "primary mode of action."

Organizations in this Story

US Food and Drug Administration

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FDA Reporter