Bradley Merrill Thompson and James Boiani Mentioned in “Breaking Down the Regulation of LDTs: Access to Innovative IVDs”

Medical Design Technology

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, and James Boiani, Senior Counsel in the Health Care and Life Sciences practice, were mentioned in an article titled "Breaking Down the Regulation of LDTs: Access to Innovative IVDs." Thompson and Boiani are based in the Washington, DC, office.

Following is an excerpt:

During the past few weeks, I've been reporting on a letter that Bradley M. Thompson, JD, and James A. Boiani, JD, attorneys at Epstein Becker Green, recently sent to FDA Commissioner Margaret Hamburg. The attorneys sent this letter on behalf of the Combination Products Coalition (combinationproducts.com), an association of drug, biologic, medical device, and IVD manufacturers dedicated to working with FDA to improve the regulation of combination products. In the letter, they discussed the regulation of laboratory-developed tests (LDT) and made the argument for creating a single regulatory framework for IVDs and LDTs. This week's blog presents further information from this letter.