Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Combination Products Coalition Zeroes in on Autoinjectors and Personalized Medicine."
Following is an excerpt:
The Combination Products Coalition has launched an effort to obtain regulatory clarity in two specific areas: autoinjectors and personalized medicine. ...
"Our objective is to at least make sure that the FDA understands what the questions are that need to be answered," said Thompson, a partner with EBG and general counsel for the coalition.
"That might help the agency. Sometimes when they're just trying to respond to general confusion, they're not sure truly where we're struggling, the questions that we're struggling with, and I think it helps the agency to at least know where industry's struggling for a lack of clarity." ...
"One of our important motivations in this regard is that whenever we talk with FDA, it gets really tough, unless you get a little bit more specific about the products, to get clarity from the agency because combination products cover such a diverse range of products," Thompson said. ...
Thompson is hoping that the coalition's input will help provide a starting point for FDA's policymaking on the two product types. The guidance process works best, Thompson said, "when FDA starts from a clear understanding of where the industry is struggling, and I don't think industry takes the time often enough to really articulate where they're unsure of what the law is."
