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
Fixing / Demolishing the 510(k)
The changes IOM proposes are both radical and entirely sensible
Monday, August 01, 2011
The changes IOM proposes are both radical and entirely sensible
Monday, August 01, 2011
FDA + NGS = BFFs
We may be talking about a whole new regulatory paradigm when it comes to next-gen sequencing
Friday, June 24, 2011
We may be talking about a whole new regulatory paradigm when it comes to next-gen sequencing
Friday, June 24, 2011
IVD Roundtable Meeting Recap
No knights, but plenty of great discussion nonetheless.
Monday, June 13, 2011
No knights, but plenty of great discussion nonetheless.
Monday, June 13, 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
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
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
LDTs Losing Enforcement Discretion?
FDA no longer feels the need to bargain with industry about LDTs.
Wednesday, June 16, 2010
FDA no longer feels the need to bargain with industry about LDTs.
Wednesday, June 16, 2010
Clove Madness
You're not supposed to admire the work of lobbyists, but this is pretty impressive.
Monday, November 30, 2009
You're not supposed to admire the work of lobbyists, but this is pretty impressive.
Monday, November 30, 2009
More Than Enough of a Good Thing
What might it look like if FDA were tasked with including outcomes in its regulatory decisions?
Friday, October 30, 2009
What might it look like if FDA were tasked with including outcomes in its regulatory decisions?
Friday, October 30, 2009
The Incredible Shrinking LDT
I think it's safe to say that there is a shift in thinking at OIVD since Steve Gutman's departure.
Tuesday, September 22, 2009
I think it's safe to say that there is a shift in thinking at OIVD since Steve Gutman's departure.
Tuesday, September 22, 2009
The Right Balance
What are they actually asking for by urging a "risk-based" regulatory framework for IVDs and LDTs?
Friday, May 08, 2009
What are they actually asking for by urging a "risk-based" regulatory framework for IVDs and LDTs?
Friday, May 08, 2009
Can I Get an EUA Too?
The short answer is no, you probably can't get an EUA. Not unless you're the CDC or the stars have all come together for you just right.
Thursday, April 30, 2009
The short answer is no, you probably can't get an EUA. Not unless you're the CDC or the stars have all come together for you just right.
Thursday, April 30, 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
Rumors
At this point, it's safe to say that IVDMIA will not be enacted under the Bush Administration.
Sunday, January 18, 2009
At this point, it's safe to say that IVDMIA will not be enacted under the Bush Administration.
Sunday, January 18, 2009
Is Your CEO Going to the Slammer?
Truth be told, there's not a lot of doors being kicked in or jail time being handed down to IVD executives of established companies.
Wednesday, December 31, 2008
Truth be told, there's not a lot of doors being kicked in or jail time being handed down to IVD executives of established companies.
Wednesday, December 31, 2008
The Wild West Gets Running Water
There are, in effect, two classes of regulation. Some products undergo rigorous testing and others simply don't.
Friday, November 21, 2008
There are, in effect, two classes of regulation. Some products undergo rigorous testing and others simply don't.
Friday, November 21, 2008
"Serious Misconduct" Alleged at CDRH
The more power an FDA approval holds, the more pressure may be brought to bear on those who make evaluations.
Tuesday, November 18, 2008
The more power an FDA approval holds, the more pressure may be brought to bear on those who make evaluations.
Tuesday, November 18, 2008
What Does An Obama Win Mean?
It seems sensible to assume that the low-hanging fruit will be the first picked.
Thursday, November 06, 2008
It seems sensible to assume that the low-hanging fruit will be the first picked.
Thursday, November 06, 2008