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’s Pharmaceutical Law & Industry Report, in “FDA’s Combo Products Report Good First Step, Lawyers Say,” by Michael Williamson.
Following is an excerpt:
“At the same time, we do think there are other steps the agency could take to strengthen combination product review, beyond those noted in the report,” Thompson told Bloomberg BNA in an e-mail.
Thompson said one example of an idea is developing a consensus combination product review plan with input from both the reviewing centers as well as the product sponsor. “Such a plan may help with the organization of the review in all of its complexity, and indeed facilitate the communication objective that FDA notes,” according to Thompson.
In addition, Thompson called on the FDA to update the intercenter agreements on combination products and flesh out the OCP’s roles and responsibilities in the review process. The OCP should “take on a more proactive role in not just resolving disputes through informal mediation but in monitoring the combination product review process,” he said.