Bradley Thompson quoted on Drug Companies’ Hopes for Combination Product Policy Development

The Pink Sheet

Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted in an article on potential new developments in combination product regulation.

The article, "Industry Hopes FDA's New Combo Products Chief Speeds Up Pending Rules," reported that the drug and device industry is eager for new developments in combination product policy. Thompson indicated that proposed rules on combination-product good manufacturing practices and adverse event reporting have not yet been released, though they were listed in the FDA's semiannual agenda in 2006. He also described the industry's concerns that the agency may inadvertently be losing focus on combination product regulatory and policy development, as the agency is forced to deal with more "routine" combination product functions, such as jurisdictional determinations.