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 CWWeekly (A CenterWatch Publication), in “Innovation Initiative to Modernize the FDA,” by Karyn Korleth.
Following is an excerpt:
“Since the 21st Century Cures Act was enacted in the final days of the Obama Administration, one might worry that the Trump Administration would not embrace it. But that is simply not the case. The FDA seems to be implementing it with zeal. And indeed, that’s the benefit of having produced the 21st Century Cures Act in a bipartisan manner,” says Bradley Merrill Thompson, a lawyer with the firm Epstein Becker & Green, whose specializes in FDA and clinical trial issues. “The FDA is enthusiastically embracing the idea embedded in the legislation that the FDA has a responsibility to ensure that innovation flourishes. I really have to applaud the FDA for this initiative.” …
“I am very glad to see that the FDA is investing in upgrades to its IT infrastructure that will allow it to make maximum use of some of the software analytics that will help the FDA spot potential safety risks, but also do so quickly and with the least burden on industry applicants,” said Thompson. “We’ve made great strides in computer modeling and simulation the folks in industry have been now using for a while. Putting the FDA in the position to likewise use those techniques is a real step forward that will both enhance safety and lessen the regulatory burden.”