Report: CDER, CDRH Need to Better Mesh Policies on Combo Products

The FDA’s Office of Planning is calling for better coordination and communications between CDER and CDRH to facilitate reviews of a growing tide of combination therapies.

In a new report, the FDA says the two centers have different policies, practices and application types and standards for approving products, particularly with respect to NDAs and device 510(k) submissions.

It finds that differing review times and approaches to managing the review process inhibit effective coordination. Lack of access to each other’s data systems and lack of shared technical platforms are seen as significant sources of delay and inefficiencies. Additionally, the lack of clarity in communications channels results in staff being unsure of where to direct consultation requests.

The report calls for the creation of guidance documents specific to combination products that detail data expectations and other critical review considerations. It also calls for reviewers involved in the review of combination products to have access to each other’s data systems.

The report also calls for a working group to review and update the agency’s manual for intercenter consultative/collaborative review processes, which was last revised in 2004, and establish a combination product-specific organizational chart and contact directory that is updated regularly and available on the Office of Combination Products website.

In an Oct. 14 memorandum to staff, FDA Deputy Commissioner Robert Califf, and President Barack Obama’s nominee to become the next commissioner, praised the assessment and said the agency is already making strides toward implementing many of the recommendations.

Read the report at www.fdanews.com/10-19-15-ComboReport.pdf. — Kellen Owings