FDA’s head of combination products eyes new guidance in next quarter

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Thinh Nguyen (left) and John Weiner (right)

COLUMBUS, OH — The U.S. Food and Drug Administration’s (FDA) Office of Combination Products (OCP) has seven priority guidelines under development, which OCP Director Thinh Nguyen hopes will 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 provided an overview of the office’s ongoing work and priorities, including issuing guidance on the following seven topics:

  • Human factors for combination products (final guidance)
  • Essential Performance Requirements: Established Conditions and Combined Products (Draft Guidance)
  • Technical Considerations for Demonstrating the Reliability of Emergency Injectors (Final Guidance)
  • Combined-Use/Cross-Labeled Combination Products (Draft Guidance)
  • Post-marketing modifications of combination products (draft guidelines)
  • Unique Device Identifiers and Combined Products (Guidance Draft)
  • Insulin Pump Labeling Considerations

Nguyen said To concentrate that the guidelines are currently going through the process of review and approval in parallel, and that it is unclear when they will be ready.

“All of a sudden we might get three in the same week and then another one in a month, we really don’t know because once they’re in that clearance process they’re no longer between our hands,” he said. “The question is how many resources does the (FDA) Chief Counsel have to look at this stuff.”

Nguyen said with the holiday season approaching, the guidelines are unlikely to be released this year. Instead, he said it was more likely the guidance would start being released in the first quarter of next year.

Although the process for obtaining the guidelines is the same as for other product centers, Nguyen said that the fact that OCP guidelines must be approved 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 advice because they just have to go through their center, but now you have to go through three different centers,” Nguyen said. “It just takes longer.”

Weiner notes that the process typically involves OCP creating advice and gaining consensus among other product centers with subject matter expertise through a working group that may also include representatives from the OCP office. FDA Chief Counsel. If consensus is not reached, the matter can be taken to the center leaders who try to help overcome the obstacles.

Then the guidelines are sent to the Office of the Chief Counsel for clearance, where they tend to spend most of their time according to Weiner before being sent to the FDA Policy Office for clearance. Finally, other Department of Health and Human Services (HHS) stakeholders may want to review the guidelines before they are released, depending on the topic he added.

“The clearance process itself, in my experience, is taking longer and longer and in some ways that’s a good thing, but it’s frustrating,” Weiner said. He said that in his experience, the iterative process that guidance goes through adds value, although it can slow down the process.

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