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
Implausible Deniability
Delegation is not a defense. Ignorance does not negate liability.
Tuesday, October 26, 2010
Delegation is not a defense. Ignorance does not negate liability.
Tuesday, October 26, 2010
Putting the "Lab" Back in LDTs
Clinical labs: FDA is not interested in shutting you down after the LDT meeting
Thursday, July 29, 2010
Clinical labs: FDA is not interested in shutting you down after the LDT meeting
Thursday, July 29, 2010
It's My Genome and I'll Do What I Wanna
Mr. Biggers deserves a clear, direct answer to his LDT meeting questions
Thursday, July 22, 2010
Mr. Biggers deserves a clear, direct answer to his LDT meeting questions
Thursday, July 22, 2010
A Hearing... but not a Listening
These aren't new rules. You don't get to keep doing what you're doing.
Monday, July 19, 2010
These aren't new rules. You don't get to keep doing what you're doing.
Monday, July 19, 2010
LDT: Legal Distinction Terminated
OIVD will no longer observe a significant distinction between IVDs and LDTs.
Monday, June 21, 2010
OIVD will no longer observe a significant distinction between IVDs and LDTs.
Monday, June 21, 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
Pathway's Looming World of Hurt
Thank your for your willingness to invite FDA enforcement in public.
Wednesday, May 12, 2010
Thank your for your willingness to invite FDA enforcement in public.
Wednesday, May 12, 2010
FDA Trims the Astroturf
FDA may actually expect you to behave the way you're supposed to.
Thursday, May 06, 2010
FDA may actually expect you to behave the way you're supposed to.
Thursday, May 06, 2010
Four Eighty Threes, Three French Hens...
Hopefully you've never been issued a warning letter, so I'd like to walk you through what a typical one looks like.
Monday, December 21, 2009
Hopefully you've never been issued a warning letter, so I'd like to walk you through what a typical one looks like.
Monday, December 21, 2009
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
Headed to the Hoosegow
Those of us who manage to pursue our work in a more conscientious manner shouldn't worry too much.
Tuesday, November 10, 2009
Those of us who manage to pursue our work in a more conscientious manner shouldn't worry too much.
Tuesday, November 10, 2009
"Square One" for IVDMIA?
FDA is probably executing a strategic retreat, not signaling their surrender.
Friday, August 14, 2009
FDA is probably executing a strategic retreat, not signaling their surrender.
Friday, August 14, 2009
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
A New, Tougher FDA?
The days of "black box" LDTs are likely drawing to a close.
Wednesday, July 29, 2009
The days of "black box" LDTs are likely drawing to a close.
Wednesday, July 29, 2009
Making Progress by Crushing Dreams
Some dreams really need a good crushing in order for marketplace credibility to survive.
Thursday, May 28, 2009
Some dreams really need a good crushing in order for marketplace credibility to survive.
Thursday, May 28, 2009
A Statement of (Unreviewed) Beliefs
Sure, I got my information from a television commercial, but if you can’t believe television, what can you believe?
Wednesday, May 27, 2009
Sure, I got my information from a television commercial, but if you can’t believe television, what can you believe?
Wednesday, May 27, 2009
Too Good to be True?
Perfection is a worthy goal, but it's not often we get to see it out in the field.
Monday, May 04, 2009
Perfection is a worthy goal, but it's not often we get to see it out in the field.
Monday, May 04, 2009
Tchotchkes
Looks to me like 'moderation' is going to be a philosphy we will all be pushed to embrace in 2009.
Wednesday, December 31, 2008
Looks to me like 'moderation' is going to be a philosphy we will all be pushed to embrace in 2009.
Wednesday, December 31, 2008
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
"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