In March, the FDA spearheaded a lean management model that will transform the combination product review process. Now, the federal agency has introduced a new committee that will address industry policy issues, a change that could have a significant effect on manufacturers. The Combination Products Policy Council will centralize the classification and review process, which, the FDA claims, will “ensure alignment and consistency” across the board. But will the reforms really help with combination product decision-making?
A New, Centralized Consultation Process
As each FDA center currently uses a different review method — and combination product approval usually involves more than one center — effective cross-division coordination can be a challenge, as can communication of the review process. For example, manufacturers have been confused about which lead review center will investigate their combination product.
In October 2015, the FDA realized there were problems. “There is a lack of clarity regarding cross-center communication channels,” it said. “Being unable to access other Centers’ data systems in a timely manner and lack of a shared technical platform were seen as a significant source of delays and inefficiencies in the consult process.”
The Future of Combination Product Review
The Combination Products Policy Council plans to overcome these hurdles by modernizing the inter-center consultation process. The committee will be made up of representatives from various FDA divisions and industry experts.
The FDA plans to “promote alignment in addressing challenging medical product classification issues.” This collective vision could see several teams working closer together, speeding up response times and streamlining the approval process. Also, the committee will establish a new communication strategy so products are brought to market in a speedier time frame.
Challenges Facing the FDA
Exactly how the Combination Products Policy Council plans alignment remains unclear. Because regulatory and statutory requirements for different application types, such as review limitations and data requirements, vary, they could pose a significant obstacle to alignment if the committee plans to standardize as many processes as possible.
Then there’s the likely bureaucracy involved with the creation of a new committee. Manufacturers have had to deal with product review delays in the past and hope a centralized council won’t hinder decision-making.
The Combination Products Policy Council plans to address some of the classification challenges that have frustrated manufacturers, improve communication and foster the development of safe combination products. Manufacturers trust the FDA will strengthen the review and approval process without getting caught up in red tape.
Do you want to improve your chances of getting your combination product to market? Contact us at Quality Solutions Now (QSN), and we can ensure your product meets Combination Products Policy Council compliance standards