Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was featured in Bloomberg BNA Medical Devices Law & Industry Report, in “Include Risk Tolerance Info in Device Approval Requests: FDA,” by Michael D. Williamson. (Read the full version – subscription required.)
Following is an excerpt:
As for updating the guidance without going through notice and comment, attorney Bradley Merrill Thompson told Bloomberg BNA Aug. 22 the FDA doesn't typically do this, but it has been done before. Frankly, it's not concerning unless the FDA makes significant changes to a guidance document without first seeking comments on it, said Thompson, who represents device companies at Epstein Becker & Green PC in Washington.
