Bradley Merrill Thompson Quoted in “FDA Draft Guidances Drag Out”

Medical Device and Diagnostic Industry

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "FDA Draft Guidances Drag Out."

Following is an excerpt:

At the end of the 2013 fiscal year last September, the law firm Epstein Becker & Green conducted a study of the outstanding draft guidance documents issued by CDRH. They found more than 90 proposed guidances that have never been finalized, including many that have been languishing for more than five years.

"Once FDA publishes a proposed guidance, for the most part, they've accomplished what they want to accomplish, which is letting everyone know what they think," says Bradley Merrill Thompson, a member of the firm and leader of its medical device regulatory practice. "The step then of listening to public comments and making revisions is of interest to the public but obviously not so much to the agency. It ought to really rankle people to know that FDA puts this stuff out in draft form and often begins to use it regardless of the comments received."