by Michael Grabell, ProPublica
Blog
U.S. FDA establishment registration renewal deadline extended
By Stewart Eisenhart, Emergo Group
FDA report claims improved 510(k), PMA review times
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has published a new report showing small but consistent reductions in review times for 510(k) premarket notification as well as premarket approval (PMA) submissions for medical devices.
Doctors’ 2012 33% tax hidden tax hike
Physicians were the subject of a 33% tax hike that most of them weren’t even aware they received this year.
That’s right. Thirty-three percent.
Couched as "only five additional dollars each month" by the government, it passed because doctors don’t make the Federal Register part of their weekly reading list and because our professional lobbying organizations were either asleep at the wheel or distracted by the whole health care reform mess.
On folding
Every surgeon has been there at some time in their career.
It’s a horrible, exhausting feeling.
Yet one we all must come to grips with: knowing when to stop.
A new law advances public health: New web page tracks progress
By: Malcolm Bertoni and Leslie Kux
After Congress passes a law that affects how FDA carries out its public health mission, we must begin the task of implementing the law – that is, putting the law into effect and enforcing it.
For a major piece of legislation like the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July, this is a complex undertaking.
A novel idea for managing consent
In 2008, I wrote about representing privacy preferences in an XML form that I called the Consent Assertion Markup language (CAML).
Joint Australia-New Zealand medical device regulatory system closer to implementation
By Stewart Eisenhart, Emergo Group
The next generation of entrepreneurs
When I was 13 years old, the Altair 8800 appeared on the cover of Popular Electronics. By 16, I was building enough hardware and software that I achieved the Malcolm Gladwell 10,000 hours of competency by age 18. By 19, I founded a company that produced tax calculation software for the Kaypro, Osborne, and new IBM PC. Every week in the Silicon Valley of the early 1980’s brought a new startup into the nascent desktop computer industry.
Politics in major medical journals
The little-known provision of Obamacare that could have a big, bad impact
by David Lucchino, published by WBUR Boston’s Cognoscenti blog
David Lucchino: The 2.3 percent excise tax on the medical devices sector would hamper innovation, force layoffs and cripple loss-making start-ups. (Alex E. Proimos/flickr)