INDUSTRY WANTS FDA TO ADOPT UNIFIED STANDARDS FOR COMBINATION PRODUCTS
Because all FDA centers and various regulations are involved with combination products, whatever is happening with them will have an impact on all other products, Mason Diamond, vice president of clinical and regulatory affairs for TyRx Pharma, said.
Diamond, whose company manufactures devices, drugs and combination products, spoke at a Jan. 10 audioconference sponsored by the Regulatory Affairs Professionals Society.
"Combination products have always been challenging," Diamond said. For example, the FDA's MedWatch form has a space in which to list combination products, but the agency still doesn't have a database for them, he said.
In March 2006 the industry-led Combination Products Coalition offered near-, mid- and long-term proposals for the agency to consider in formulating guidance on combination products, Diamond added.