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FDA approval process must balance rigor and haste (Best of MedCitizens)

Every week, MedCity News highlights the best of its MedCitizens: syndication partners and MedCity News readers who discuss life science current events on MedCityNews.com. Now here’s the best of what YOU had to say.

Every week, MedCity News highlights the best of its MedCitizens: syndication partners and MedCity News readers who discuss life science current events on MedCityNews.com.

Now here’s the best of what YOU had to say:

When it comes to FDA product approval, we just can’t have it all. “The truth is that Americans cannot have it both ways. We cannot have a zero tolerance for adverse events and simultaneously demand more rapid FDA approval of very invasive products. And, it is naive to expect equivalent safety and efficacy without FDA regulation.”

NIH pledges $143.8M for biomedical innovators and risk-takers. “The National Institutes of Health recently announced that it is awarding $143.8 million to challenge the status quo with innovative ideas that have the potential to propel fields forward and speed the translation of research into improved health for the American public.”

Careful, but quick, crafting needed for physician disclosure database. “The rule must be quite specific as to the structure of the database, and require every company filing conform to its data requirements. The law was not intended to build a forest in which it becomes impossible to spot individual trees.”

Medical malpractice not a major driver of healthcare costs. “I smiled when I read that some physicians were taking the case for medical malpractice reform to the congressional super committee that is charged with cutting the federal deficit. It’s emblematic of what cynics might expect of the committee  — that at best it will be able to agree on exciting sounding ideas that turn out to yield little to no savings. Medical malpractice policy is a serious issue that deserves to be debated, but it’s not a major driver of health care costs.”

Optimize your medical device FDA submissions with imaging analysis. “Total review times for 510(k) submissions have increased by more than 55 percent since 2005 because of poor quality submissions by medical device manufacturers, according to a July 2011 FDA report. Tim Kulbago, President & CEO of ImageIQ, tells us how to increase funding and improve regulatory approvals with extremely powerful imaging data.”

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