FDA combination products chief eyes new guidances next quarter

COLUMBUS, OH – The Office of Combination Products (OCP) at the US Food and Drug Administration (FDA) has seven priority guidances in development, which OCP Director Thinh Nguyen hopes will be published in the first quarter of 2023.

Nguyen and John Weiner, OCP associate director for policy, spoke at the Combination Products Summit 2022 hosted by the Regulatory Affairs Professionals Society (RAPS) and the Association of Food and Drug Officials (AFDO). The two officials gave an overview of the office’s ongoing work and their priorities, which include publishing guidance on the following seven topics:

Human factors for combination products (final guidance)
Essential performance requirements: established conditions and combination products (draft guidance)
Technical considerations for demonstrating reliability of emergency-use injectors (final guidance)
Combined use/cross-labeled combination products (draft guidance)
Postmarket changes to combination products (draft guidance)
Unique device identifiers and combination products (draft guidance)
Labeling considerations for insulin pumps

Nguyen told Focus that the guidances are currently going through the review and clearance process in parallel, and that it's hard to pinpoint when they'll be ready.

"All of a sudden we might get three of them cleared in the same week and then another in a month, we really don't know because once they're in that clearance process, they're out of our hands,” he said. “The question is how much resources the (FDA) chief counsel has to look at that kind of stuff."

Nguyen said that with the holiday season coming up, it’s unlikely that the guidances will come out this year. Rather, he said it’s more likely the guidances will start being published in the first quarter of next year.

While the process to get guidances cleared is the same as other product centers, Nguyen said that the fact that OCP guidances need to be cleared by multiple product centers tends to slow things down.

“The clearance process for combination products is going to be more complex than just a device or drug guidance because they just have to go through their center but now you have to go through three different centers,” said Nguyen. “It just takes more time.”

Weiner notes that typically the process involves the OCP creating guidance and getting consensus among the other product centers with subject expertise through a working group that may also include representatives from the FDA chief counsel’s office. If consensus isn’t reached, the issue can get elevated to the center heads who try to help overcome any hurdles.

Next the guidance is sent to the chief counsel’s office for clearance where it tends to spend the bulk of its time according to Weiner before being sent to the FDA’s Office of Policy for clearance. Finally, other stakeholders in the Department of Health and Human Services (HHS) may want to see the guidance before it is published depending on the topic he added.

“The clearance process itself in my experience is getting to be a bigger and bigger portion of the time and in some ways it’s a good thing, but it is frustrating,” said Weiner. He said that in his experience, the iterative process that guidances go through does add value, though it can slow down the process.

FDA combination products chief eyes new guidances next quarter

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