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 Pharma & MedTech Business Intelligence’s The Gray Sheet, in “FDA Meets With Clinical Decision Support Firms to Address Challenging Cases.”
Following is an excerpt:
Thompson says the coalition is not interested in having its use cases included in the upcoming CDS draft guidance. He estimates it takes about four years for FDA to release a guidance, and adding this new element could delay the document.
“I explicitly told them, from my standpoint, I did not want to suggest that they wait … to address these questions in that CDS guidance because I knew that would slow down that guidance,” he said. “It covers an awful lot of topics. I don’t think [the guidance is] written to be very focused on the pharmaceutical case studies. I think it’s more typical of what you’d see in an electronic health record for data analysis.”