Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg BNA Medical Devices Law & Industry Report, in “Drug/Device Combo Makers Get Clarity on Manufacturing Requirements,” by Bronwyn Mixter. (Read the full version – subscription required.)
Following is an excerpt:
Bradley Merrill Thompson, the general counsel for the Combination Products Coalition, an industry group, told Bloomberg BNA in a Jan. 11 e-mail the CPC is “delighted to see this final guidance.”
“When FDA comes out with a new regulation, typically the regulation is written at such a high level that it leaves a lot of questions unanswered. Guidance fills that critical need,” said Thompson, who is also a Washington-based attorney with Epstein Becker & Green PC. “We are particularly delighted that FDA has been incorporating into its guidance not only answers to questions, but case studies that illustrate how FDA approaches these issues. This is a good guidance document.”
