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 Inside Health Policy, in “Software Coalition to FDA: Revamp Guidance Approach by Using Advisory Opinions,” by Nicholas Florko. (Read the full version – subscription required.)
Following is an excerpt:
"We think FDA should develop a new, additional approach to guidance beyond the traditional lengthy and comprehensive guidance document that covers an entire field or regulatory topic," wrote Bradley Merrill Thompson, attorney at Epstein, Becker & Green and general council for CDSC, in an Aug. 16 citizen petition to FDA on behalf of the coalition.
"FDA's existing guidance practices do not meet the needs of innovators," Thompson added in a statement to Inside Health Policy. "While a certain amount of lag time by the agency is understandable as FDA learns about new therapies and carefully thinks through the regulatory implications, right now the agency is falling so far behind in producing guidance on new technology that it is stymieing innovation."
The group disagrees with FDA's argument that good guidance practices prevent the agency from issuing advisory opinions.
