Combination product review gets a regulatory revamp

Knowing the process can be stressful, the FDA is setting new guidelines to make it easier.

As products become more advanced, the regulations to make sure they are safe can become more complicated.

The FDA is well aware of this and has a new plan to make it a little less stressful when it comes to reviewing therapeutic and diagnostic combination products.

"While we already have policies and processes in place to address such issues, we know we can do more," wrote Robert M. Califf, M.D., FDA’s Deputy Commissioner for Medical Products and Tobacco and Jill Hartzler Warner, J.D., FDA’s Associate Commissioner for Special Medical Programs, in a joint blog post on FDA Voice.

"To that end, we’ve recently conducted a focus group study with reviewers from the different Centers based on input from industry to assess how we’re doing. The report confirmed that differences in communication, policies, practices, systems and application types can be challenging when the Centers work together on a review of a combination product."

As a result, there are several steps the agency has outlined to make this process easier:

  • Issuing more guidance for review of combination products (e.g., our pending draft guidance document on human factors)
  • Enhancing and simplifying data access and sharing for internal staff
  • Making it easier for staff to request and monitor inter-center consults
  • Updating and maintaining our internal contact directory for experts to review a combination product; and improving our internal standard operating procedures for premarket reviews and compliance activities.
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