FDA creates best practices for combination product developers

Dive Brief: FDA is seeking feedback on how it communicates with developers of combination products. […]

Dive Brief:

  • FDA is seeking feedback on how it communicates with developers of combination products.
  • In draft guidance published Monday, FDA describes best practices for regulatory communication involving combination products and outlines feedback mechanisms.
  • The publication comes days after FDA released draft guidance on bridging information on products featuring different combinations of drugs and devices.

Dive Insight:

The 21st Century Cures Act requires FDA to provide final guidance on aspects of the submission process including how companies should obtain feedback from the agency. That requirement led to the release of draft guidance titled “Requesting FDA Feedback on Combination Products.”
In the text, FDA defines combination products as “any combination of a drug, a device, and/or a biological product” before outlining how it reviews and regulates the category.
The core of the document is focused on best practices for interactions between sponsors and FDA and the mechanisms through which the agency provides feedback on combination products. In the section on best practices for sponsors, FDA calls for developers of combination products to pose clear and appropriate questions, provide comprehensive supporting information and communicate with the agency through a dedicated point of contact.
FDA thinks sponsors that follow those best practices will be more likely to have efficient and productive interactions. The agency is also keen for its staff to take steps to ensure that outcome.
With that in mind, FDA is calling on its staff to give sponsors the details of their points of contact, engage colleagues in other teams relevant to a product early in the review process, consolidate feedback and provide reliable advice.
Another section of the guidance describes the ways sponsors can interact with, and obtain feedback from, FDA. Most of that section is given over to Combination Product Agreement Meetings, which FDA offers to provide sponsors with “clarity and certainty.”
The document is the second combination product draft guidance published by FDA in the past week. In the earlier text, FDA offered advice for companies that want to change a combination product so it features either a different drug or device.
A sponsor could find itself in that situation if, for example, it decided to deliver its drug via an autoinjector rather than a prefilled syringe part during the development process. That sponsor would have data on the prefilled syringe version of the product that may or may not be relevant to the autoinjector variant. To establish the relevance of the prefilled syringe data, FDA would expect the sponsor to develop a framework for identifying information gaps.
FDA is accepting feedback on the combination product communication draft until Feb. 24. The comment period for the guidance on bridging drug-device information closes on Feb. 18.

Original Article: (https://www.medtechdive.com/news/fda-creates-best-practices-for-combination-product-developers/569611/)