FDA Looks to Expedite Combination Product Reviews With Pilot Program

The FDA is confronting institutional drawbacks to developing combination products with a pilot program meant to improve the current review process.

The newly unveiled pilot effort will start in select offices within CDER, CBER and CDRH before gradually spreading to all offices within the three centers sometime next spring.

This program, dubbed the intercenter consult request process, addresses policy and review problems associated with approving a product that falls under multiple regulatory categories, such as a drug-device combination. In the past, the agency noted issues with the timeliness of reviews for combination products.