Bradley Thompson Quoted on Combination Product-Makers’ Impatience with FDA

The Gray Sheet

Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted on the issue of combination product companies growing frustrated with the U.S. Food and Drug Administration's slowness in issuing key rules and guidance documents.

In the article, "Combo Product Firms Lose Patience As Regs, Guidance Are Delayed Again," Thompson said: "Our concern is that FDA—through inadvertence, not through intention—is not paying a whole lot of attention to combination products." Combination product companies, said Thompson, want the next FDA commissioner to raise the profile of combo product issues within the agency.

"Our number one concern is that the agency focus more on combination products, that they give that subject matter a higher priority, and that they start moving the freight on these important policy issues," he said.