Bradley Merrill Thompson Quoted in Article, “MRC Pushes for More Time on FDA’s Mobile Medical App Guidance”FierceMobileHealthcare January 26, 2012
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 "MRC Pushes for More Time on FDA's Mobile Medical App Guidance," by Sara Jackson.
Following is an excerpt:
In a bit of a surprise move, the mHealth Regulatory Coalition has asked the U.S. Food and Drug Administration to revamp and republish its proposed guidance for mobile medical apps--but as a second draft, not a final regulation.
MRC made the request in a letter, crafted by founding member and attorney Bradley Thompson.
"[C]ore elements cannot simply be cleaved off," Thompson writes. "[T]he integrity of the guidance system requires that FDA give public comments serious, mature consideration and respond with appropriate modifications, not just promises of future action."