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 POLITICO Morning eHealth, in “FDA Concerns: Drugs and Devices.”
Following is an excerpt:
That sort of stance might be problematic for the industry. While Epstein Becker & Green’s Bradley Merrill Thompson doesn’t know the details of the specific requests FDA made, he’s concerned that this might be a trend. “While I have no inside information on what happened, of late I’ve been hearing many sponsors of combination products express concerns that human factors experts within the agency — at CDRH and CDER — are not on the same page,” he told your correspondent.
He concluded, “I am concerned that this might be another indicator that FDA is shifting its view on such requirements and may not be speaking with one voice.”