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FDA scientists plea for agency reform – Technology will help with Transparency

Posted Jan 11 2009 4:20pm

One of the real benefits of technology is that with software, 10 people can collaborate and review the same files, big breakthrough or surprise here?   Of course it is and with having transparency instead of a paper folder tucked away somewhere, this will do wonders.  Managers and scientists alike will be able to collaborate and know what the other is doing at all times, like a nice Share Point Server can do. 

As reported earlier this year some reports were still being written in longhand on paper!   You can see my somewhat sarcastic call out to Intel below to get all the folks at the FDA some “classmates” (inexpensive computers) that would be affordable if money and budgets were the issue (grin). 

Collaboration and Transparency are the name of the game today and it involves everyone using technology, like it or not, it’s part of the world we live in today.  BD 

From a post earlier this year:

Next bunch, the FDA, they too were writing studies up long hand up until not too long ago and I can reflect back on a somewhatsarcastic comment I made in Februaryabout helping the FDA with some inexpensive "Classmate" computers from Intel.  It is absolutely amazing what folks "don't" and "won't" work with.  So, now we have 2 entities still writing up studies and results in long hand, doctors wrote them up that way, FDA analyzes and wrote up a long hand report, so what's up with this!  Sounds like we have a 2 part issue here.

And one more:  

On a prior post it was noted that the FDA needs some new technology...as the article states that key employees were still writing these things out in longhand...on paper...as technology continues to grow, those in responsible positions could certainly benefit with some technology updates, at least with hardware for a start...

Hello Intel...anybody listening...maybeCraig Barrett...could we get someClassmatesover there to help out??  BD

The scientists say managers have demanded and intimidated FDA scientists to manipulate data, the Wall Street Journal reports, and honest employees can't act with integrity without fear of reprisal. "There is an atmosphere at the FDA in which the honest employee fears the dishonest employee," the letter states. The scientists say they've taken their concerns to Commissioner Andrew von Eschenbach and others, but no action was taken.

FDA scientists plea for agency reform - FiercePharma

Related Reading:

Medicine is a Low Tech Business - Clinical Studies still done on paper too!

FDA Head: We're Boosting I.T.

Study Calling For Medical Device Information To Better Serve Patients And Doctors from the FDA

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