MELA Files a Citizen's Petition against FDA

Show: Health Beat of America

Dr. Joseph Gulfo
Topic Info
On July 20, 2011, at 10:30 AM EST, the Subcommittee on Oversight and Investigations held a hearing entitled “Regulatory Reform Series #5 - FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs.” This is very timely, since This is very timely, since MELA Sciences recently took the unusual step of filing a Citizen's Petition against FDA, arguing that the agency is reneging on a binding protocol agreement it had signed relating to its MelaFind device, and that the delays are unnecessarily stifling innovation and are costing lives (one person dies every hour in the US from melanoma), as well as jobs.

Dr. Joseph Gulfo, CEO of MELA Sciences, will can shed light on their case with the FDA, and speaks strongly to how these regulatory delays are impacting the country’s health, as well as the medtech industry.
Rochelle Herman
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