Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was featured in Bloomberg BNA Medical Devices Law & Industry Report, in “FDA Unveils Updated Combination Products Effort,” by Michael Williamson.
Following is an excerpt:
“Obviously, from a resource standpoint, achieving efficiency is important,” Thompson told Bloomberg BNA, adding, “But we are even more excited about the goals of enhancing ‘communication and coordination among the groups that oversee the development, review, and approval of combination products.’”
However, Thompson criticized the agency for not addressing the need to communicate with outside groups.
Lean management shouldn’t be strictly an internal exercise, and knowing when and how to coordinate reviews needs to involve the companies responsible for making the submissions, Thompson said.