Contributed Blogs
When regulators are ignored
By: John Roth
Medical Device Tax: Are Conservatives’ goals hampering repeal efforts?
Last week, the GOP-controlled House of Representatives cast its 37th vote to repeal, de-fund or dismantle the Patient Protection & Affordable Care Act.
The bill, which passed 229-195 along partisan lines, will do nothing to halt the forward progress of the landmark healthcare reform law and amounted to little more than allowing newly minted Republican lawmakers a chance to keep a campaign promise.
U.S. FDA to require proof of IEC 60601-1 3rd Edition in summer 2013
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration will begin requiring manufacturers and sponsors of electrical medical devices to show compliance with the standard ES 60601 3rd Edition starting June 30, 2013.
Honoring an FDA champion of safe treatments for children
By: Margaret A. Hamburg, M.D.
It has been 11 years since Congress passed the Best Pharmaceuticals for Children Act mandating the creation of the Office of Pediatric Therapeutics (OPT) at FDA. But it has been light years in terms of the progress we have made to ensure that children have access to innovative, safe and effective medical products.
FDA’s collaboration with Chinese partners gets stronger each year
By: Mary Lou Valdez
“What’s in a name?” Shakespeare famously asked. “A rose,” his Juliet reasoned, “by any other name would smell as sweet.” And often, we know, that’s true. But other times, a change in name can signify some larger, more substantive shift.
The latter was the case in mid-April when we sat down in Washington to meet with one of China’s key regulatory agencies, the China Food and Drug Administration (CFDA).
Biomedical company benefits from ADMET’s testing machine
Top 5 reasons to audit your patent portfolio in 2013
By Scott Smith
When harm in the hospital follows you home
by Olga Pierce, ProPublica
“How is it possible to move past medical harm when every single aspect of life is impacted by it – when absolutely everything a person believed about doctors, lawyers, oversight agencies, insurance companies is turned upside down and inside out?” – Robin Karr, patient harm survivor
Looking back on a pretty sedate ACC
Sometimes the major annual medical meetings are jam-packed with significant and market-moving data. And then sometimes they’re like this year’s American College of Cardiology conference, with relatively limited useful data from an investing perspective.
‘Burn the data’: Did a company try to hide risks of MRI dye Omniscan?
by Jeff Gerth, ProPublica
In 1994, a scientist studying her company’s new medical imaging dye reached troubling findings. Her boss, she recalls, told her to “burn the data.”