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 in BNA’s Pharmaceutical Law & Industry Report that discussed the current priorities of the combination product industry.
The article, titled “Combination Product Industry Seeking New Guidance on Clinical Trials, Injectors,” reported on Thompson’s comments at a conference hosted by Cambridge Healthtech Institute. Thompson reported that an overarching priority of companies making drug-device combination products is to receive better guidance from the federal government on clinical trials. However, he said, a more immediate concern is persuading regulators to consider major revisions to their draft guidance on pen, jet, and related injectors intended for use with drugs and biological products, which is open for comment until July 27.
Thompson, who is general counsel for the Combination Products Coalition (CPC), said other topics of concern include good manufacturing practices, premarket approval submissions, and cross-labeling.