Bradley Merrill Thompson Quoted in “CDS Coalition Petitions FDA for Guidance on Drug Treatment Software”CTel Center for Telehealth & e-Health Law September 6, 2016
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 CTel Center for Telehealth & e-Health Law, in “CDS Coalition Petitions FDA for Guidance on Drug Treatment Software.”
Following is an excerpt:
According to POLITICO, CDS Coalition’s general counsel, Bradley Merrill Thompson of Epstein Becker Green, indicated that “the group’s frustration stems from the agency’s propensity to give case-by-case responses rather than advance more general principles.”
“Industry simply cannot go through a consultative process every time we contemplate a new product, or change direction in product development. We have to know the rules of the road,” Thompson said.
Thompson noted, however, that traditional guidance may be a poor fit for CDS software. Providing guidance for a broad area like clinical decision support requires the FDA to come up with “principles that describe everything from simple stuff to complex operations.”