The FDA hopes to improve the review process for combination products with a pilot program that will address institutional drawbacks to developing combination products.
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.
Under the program, the agency is adopting a tiered consultation approach to speed interactions across centers involved in the oversight of these products. Through this approach, the agency intends to connect drugmakers with the appropriate experts for consultations.
The pilot program also establishes timelines for centers and submissions related to the identification of combination products and completion of consultations. In addition to a timeline, the agency is spelling out the roles and responsibilities for each of the participating centers when reviewing combination product submissions.
The agency will track these consultations through a single system electronically that provides detailed information on the combination product. The goal is to ensure reviewers always have access to the latest information. — José Vasquez