Bradley Merrill Thompson Quoted in “FDA Drug, Device Divisions Not on Same Page?”POLITICO Prescription Pulse May 2, 2016
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 Prescription Pulse, in “FDA Drug, Device Divisions Not on Same Page?”
Following is an excerpt:
Proteus was required to undergo the additional regulation although its micro-gadget won approval by the device division in 2012. (The goal of the combo product is to improve medication adherence.)
— This would be a disturbing development if it becomes a trend, says Bradley Merrill Thompson of Epstein Becker & Green. "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 said.