Archive for September 12th, 2016

Will the FDA’s Intercenter Pilot Project Improve the Combination Product Submission Review Process?

Combination products present regulatory challenges because their constituent parts must be reviewed by more than one agency center. Under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act, combination products are assigned to a lead center based on their primary mode of action. The lead center then consults with other centers that oversee one or more of the product’s constituent parts. Recognizing the need for more timely and consistent consults, the FDA recently initiated Phase 1 of its new intercenter consult request (ICCR) process for combination products. Read more »