COMBINATION PRODUCTS REPORT FOCUS OF RAPS SUMMIT

The Combination Products Coalition (CPC) intends to submit a draft report to the FDA with recommendations on how FDA intercenter agreements can be modified to better define roles and responsibilities for handling approvals, modifications and preapproval inspections for combination products.

The CPC panel -- composed of regulatory affairs professionals with pharmaceutical, biologics and medical device backgrounds -- met with industry professionals, company executives and others at a consensus summit in Baltimore to discuss major issues concerning regulation of combination products.

The goal of the summit, sponsored by the Regulatory Affairs Professionals Society (RAPS), was to address the current uncertainty regarding regulatory issues in the burgeoning field of combination products.

The difficulty surrounding the labeling of, regulatory process for and modification issues in the submission of the products' data to separate agencies, as well as the role of the FDA's Office of Combination Products, were major issues under consideration.

Panelists and audience members also raised other issues associated with combination products, including agency designation and application process submission for product modification data, as well as liability risks in labeling and cross-labeling problems.

After the CPC panel completes the report, expected by Feb. 1, it will be posted on the RAPS website for a 30-day comment period. A final version of the report will be submitted to the FDA soon afterward.