Bradley Merrill Thompson Quoted in “Attorneys Want FDA to Improve Postmarket Compliance Guidance”Bloomberg BNA Medical Devices Law & Industry Report June 24, 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 Bloomberg BNA Medical Devices Law & Industry Report, in “Attorneys Want FDA to Improve Postmarket Compliance Guidance,” by Michael Williamson.
Following is an excerpt:
The FDA “seems very much to suggest that this is for the most part a qualitative decision-making process,” where as many in industry treat it as more quantitative, Thompson told Bloomberg BNA.
Thompson said it “would be very hard to take this guidance and criticize any decision FDA makes because the guidance really lays down no clear rules. Frankly, it leaves me scratching my head sometimes to figure out what the point is in producing such a guidance.”