Combo Product Makers Must Know Their FDA Reviewers

Companies applying to market combination products must know who their reviewers are in both FDA centers involved in the review process, an expert says.

Knowing the reviewers will help firms ensure all parties get the information they need quickly, which has been an issue in the past, Joyce Frey-Vasconcells, executive director of PharmaNet Consulting, said.

During reviews of combination products, one center is designated as the lead to which the applicant is supposed to send all information.

The lead should forward information to the other center as necessary.

For example, if the Center for Biologics Evaluation and Research (CBER) is the lead center for a biologic-device product and the sponsor has a device issue, it is supposed to contact CBER, not CDRH.

“This has actually caused some delay,” Frey-Vasconcells said at an FDAnews audioconference.

If a firm sends information to address a device-related issue that should go through CBER, she recommended calling the device reviewer to inform him or her of the submission and the date it was sent “so they can be proactive and contact CBER to make sure [it] gets routed ... in a timely fashion.”