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 “FDA Report Card 2015,” an analysis of the Food and Drug Administration’s performance this year, published by Medical Device and Diagnostic Industry (MD+DI).
Following is an excerpt:
“I think this is one of the agency’s greatest weaknesses right now. FDA typically develops a draft guidance with very little interaction with industry. Then, once a draft guidance is published, the agency will leave it in draft form and move on to the next project. That means most of the guidances out there were written with very little industry input. I think we need a new approach.”