FDA Announces New "Close Enough" Standard
Class IIish products gain new latitude
Monday, April 01, 2013
Class IIish products gain new latitude
Monday, April 01, 2013
Taxing Compliance
The ambiguity of "device" takes on a whole new importance
Friday, December 07, 2012
The ambiguity of "device" takes on a whole new importance
Friday, December 07, 2012
Return of the Crystal Ball
What does an Obama re-election portend for the next four years?
Wednesday, November 07, 2012
What does an Obama re-election portend for the next four years?
Wednesday, November 07, 2012
Welcoming Our New OIRA Overlords
Will necessity and harmonization trigger a regulatory race to the bottom?
Monday, June 18, 2012
Will necessity and harmonization trigger a regulatory race to the bottom?
Monday, June 18, 2012
In-Vehicle Diagnostics
Assessing the bold future of automotive medicine
Wednesday, February 29, 2012
Assessing the bold future of automotive medicine
Wednesday, February 29, 2012
The Abolish OIVD Act of 2011
A torches-and-pitchforks approach to LDT regulations
Tuesday, October 18, 2011
A torches-and-pitchforks approach to LDT regulations
Tuesday, October 18, 2011
Finding the Right Regulation
Some regs are not as obvious as they appear
Thursday, September 29, 2011
Some regs are not as obvious as they appear
Thursday, September 29, 2011
CU Bhind gym 2day 4real, LOL -FDA
Who says the federal government doesn't get new media?
Tuesday, July 19, 2011
Who says the federal government doesn't get new media?
Tuesday, July 19, 2011
Anatomy of a Myth
Did the president just undercut clinical research standards?
Wednesday, June 08, 2011
Did the president just undercut clinical research standards?
Wednesday, June 08, 2011
Yes, That's a Device
How can software or an algorithm be considered a "device" if it's not a physical thing?
Thursday, October 07, 2010
How can software or an algorithm be considered a "device" if it's not a physical thing?
Thursday, October 07, 2010
Creating Good Connections
Everyone wants a standard whereby tubes can't be mixed up. Why don't we have it?
Thursday, September 30, 2010
Everyone wants a standard whereby tubes can't be mixed up. Why don't we have it?
Thursday, September 30, 2010
A Better 510k Webinar
What happens when your meeting has the agenda of a radio call-in show
Wednesday, September 01, 2010
What happens when your meeting has the agenda of a radio call-in show
Wednesday, September 01, 2010
I See Dead Business Models
DTCG companies are like ghosts in The Sixth Sense: dead and deeply confused
Wednesday, July 28, 2010
DTCG companies are like ghosts in The Sixth Sense: dead and deeply confused
Wednesday, July 28, 2010
The Trouble With Transparency
Sunlight may be the best disinfectant, but too much of it can cause melanoma.
Thursday, June 24, 2010
Sunlight may be the best disinfectant, but too much of it can cause melanoma.
Thursday, June 24, 2010
The Last Gasp?
It's a legal Hail Mary pass... the kind of play you attempt when you've already lost anyway.
Monday, August 03, 2009
It's a legal Hail Mary pass... the kind of play you attempt when you've already lost anyway.
Monday, August 03, 2009
Preemption: One Last Go-Round?
Preemption may, indeed, be dead, but it appears we will have another opportunity to agonize about the final decision to pull the plug.
Thursday, May 21, 2009
Preemption may, indeed, be dead, but it appears we will have another opportunity to agonize about the final decision to pull the plug.
Thursday, May 21, 2009
The Death of Preemption
FDA does not proactively author product labeling: it is up to manufacturers to seek the labeling they beleive they need.
Wednesday, March 04, 2009
FDA does not proactively author product labeling: it is up to manufacturers to seek the labeling they beleive they need.
Wednesday, March 04, 2009