Come Celebrate IVD Appreciation Month!
IVD Hall of Fame inductions begin tomorrow
Wednesday, May 01, 2013
IVD Hall of Fame inductions begin tomorrow
Wednesday, May 01, 2013
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
Reviewing the Draft Guidance on IRB Responsibilities
It's so succinct it almost fits in a Tweet!
Wednesday, February 20, 2013
It's so succinct it almost fits in a Tweet!
Wednesday, February 20, 2013
The Pre-Submission Rosetta Stone
Translating FDA's Pre-Sub guidance into CoDx language
Friday, February 01, 2013
Translating FDA's Pre-Sub guidance into CoDx language
Friday, February 01, 2013
OIG Signals Interest in LDTs
We are not taking any bets this time around
Wednesday, November 28, 2012
We are not taking any bets this time around
Wednesday, November 28, 2012
Reframing the Discussion
Should market size dictate regulatory enforcement?
Monday, November 19, 2012
Should market size dictate regulatory enforcement?
Monday, November 19, 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
Companion Diagnostics: LDTs Need Approval Too
The past is the past and tropism won't happen again
Tuesday, June 26, 2012
The past is the past and tropism won't happen again
Tuesday, June 26, 2012
LDT Guidance Documents... Where are They?
For better or worse, shouldn't we at least see them?
Friday, June 15, 2012
For better or worse, shouldn't we at least see them?
Friday, June 15, 2012
Pre-IDE: How Much is Enough?
How do I know what information to put in a pre-IDE?
Wednesday, May 30, 2012
How do I know what information to put in a pre-IDE?
Wednesday, May 30, 2012
The Dream of the 90s is Alive at CBER
OraSure's at-home HIV test delivers on 20 years of effort
Wednesday, May 16, 2012
OraSure's at-home HIV test delivers on 20 years of effort
Wednesday, May 16, 2012
Great New Companion Diagnostics E-Book Released Today
A valuable resource in a hot, but under-informed segment of the market
Monday, December 12, 2011
A valuable resource in a hot, but under-informed segment of the market
Monday, December 12, 2011
Oragene Clearance Shows DNA Stabilization is Class II
Clearance could have a significant impact on DTCG providers
Thursday, December 08, 2011
Clearance could have a significant impact on DTCG providers
Thursday, December 08, 2011
My Screening Test for Screening Tests
Offering up a rare bit of regulatory certainty
Wednesday, December 07, 2011
Offering up a rare bit of regulatory certainty
Wednesday, December 07, 2011
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
The Invisible Hand Pushes Back
A major payer proposes to restrict coverage of LDTs
Monday, October 17, 2011
A major payer proposes to restrict coverage of LDTs
Monday, October 17, 2011
New PDS More Cumbersome?
We're cautiously pessimistic on the new de novo guidance
Tuesday, October 04, 2011
We're cautiously pessimistic on the new de novo guidance
Tuesday, October 04, 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
Pathway's New World of Hurt
Finding the quickest pathway to a warning letter
Wednesday, September 28, 2011
Finding the quickest pathway to a warning letter
Wednesday, September 28, 2011
Another Important Guidance Document: Risk & Benefit
No more back-of-the-envelope risk analysis
Tuesday, September 20, 2011
No more back-of-the-envelope risk analysis
Tuesday, September 20, 2011
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
Makower Report Discredited. Again.
Grandstanding is a poor way to participate in science policy
Friday, July 29, 2011
Grandstanding is a poor way to participate in science policy
Friday, July 29, 2011
RUO Working Group: First Meeting and Agenda
Please join us by phone or at the Myraqa office
Tuesday, July 19, 2011
Please join us by phone or at the Myraqa office
Tuesday, July 19, 2011
And in Other News, Nothing Really Changed
FDA draft guidance on In Vitro Companion Diagnostics documents what we've been hearing
Thursday, July 14, 2011
FDA draft guidance on In Vitro Companion Diagnostics documents what we've been hearing
Thursday, July 14, 2011
RUO Working Group Gaining Steam
Update on our first meeting and Myraqa's draft comments on FDA guidance
Monday, July 11, 2011
Update on our first meeting and Myraqa's draft comments on FDA guidance
Monday, July 11, 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
RU O Kidding? OMG!
Draft RUO / IUO FDA Guidance Document Officially Released
Wednesday, June 01, 2011
Draft RUO / IUO FDA Guidance Document Officially Released
Wednesday, June 01, 2011
Why We're Offering Seminars
It's a bit of a departure from the standard training business model
Tuesday, February 08, 2011
It's a bit of a departure from the standard training business model
Tuesday, February 08, 2011
Rant Utility Obvious
Because "only" is such a difficult word to interpret
Thursday, December 23, 2010
Because "only" is such a difficult word to interpret
Thursday, December 23, 2010
DTCG Shenanigans
What happens when we turn scientific inquiry into a carnival attraction
Tuesday, December 21, 2010
What happens when we turn scientific inquiry into a carnival attraction
Tuesday, December 21, 2010
Entertaining Diagnostics
I'll be honest, this one really got under my skin when it happened.
Monday, December 20, 2010
I'll be honest, this one really got under my skin when it happened.
Monday, December 20, 2010
The Incredible $24 Million 510(k)
It's foolish to use early meetings as evidence of FDA burden
Tuesday, November 23, 2010
It's foolish to use early meetings as evidence of FDA burden
Tuesday, November 23, 2010
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
BRCA1 And Me
We need this test held to high standards precisely because it is so important.
Thursday, October 21, 2010
We need this test held to high standards precisely because it is so important.
Thursday, October 21, 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
Back to Basics
We're retooling and rolling out a new blog structure / focus in a couple weeks. See you then!
Tuesday, August 31, 2010
We're retooling and rolling out a new blog structure / focus in a couple weeks. See you then!
Tuesday, August 31, 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
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
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
Keep Calm and Carry On
Whoever says these words to me after Monday's LDT mtg. gets their first drink on me.
Friday, July 16, 2010
Whoever says these words to me after Monday's LDT mtg. gets their first drink on me.
Friday, July 16, 2010
No Simple Answers
Becoming a real participant begins with a willingness to engage the details.
Wednesday, June 30, 2010
Becoming a real participant begins with a willingness to engage the details.
Wednesday, June 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
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
Getting DTC Genomics Right
Personal genomics must move beyond the phase of repackaging preliminary research as actionable information.
Friday, May 21, 2010
Personal genomics must move beyond the phase of repackaging preliminary research as actionable information.
Friday, May 21, 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
Pathway's Direct-to-Recall Marketing
The perils of making a deal to sell an unapproved IVD direct to consumer.
Tuesday, May 11, 2010
The perils of making a deal to sell an unapproved IVD direct to consumer.
Tuesday, May 11, 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
Unicorns, Santa Claus and Instrument-Only Clearances
Let's be clear, though: the world has not turned topsy-turvy today.
Tuesday, May 04, 2010
Let's be clear, though: the world has not turned topsy-turvy today.
Tuesday, May 04, 2010
Biomarkers: Use With Caution
FDA has made it clear that the days of simple marker claims are over.
Monday, March 15, 2010
FDA has made it clear that the days of simple marker claims are over.
Monday, March 15, 2010
Patent (Had Better Be) Pending
The days of using the term as an empty threat may be ending.
Monday, March 08, 2010
The days of using the term as an empty threat may be ending.
Monday, March 08, 2010
IVDMIA: to NPRM or Not to NPRM?
I can't rule out the possibility that the NPRM story is true, but it's certainly not an established fact.
Friday, March 05, 2010
I can't rule out the possibility that the NPRM story is true, but it's certainly not an established fact.
Friday, March 05, 2010
Good Summary Judgment
Make it easy to understand your point. It's worth the effort.
Wednesday, March 03, 2010
Make it easy to understand your point. It's worth the effort.
Wednesday, March 03, 2010
ODE to OIVD
I wouldn't be surprised if this is the first step in a larger re-alignment of regulatory burdens.
Thursday, January 14, 2010
I wouldn't be surprised if this is the first step in a larger re-alignment of regulatory burdens.
Thursday, January 14, 2010
Birds of a Feather
Failure to recognize practical bottlenecks will prevent you from making it to the pond in time, even if you have excellent technology.
Monday, January 11, 2010
Failure to recognize practical bottlenecks will prevent you from making it to the pond in time, even if you have excellent technology.
Monday, January 11, 2010
MyRAQA Powers, Activate!
Growing more than 100% this year presents incredible opportunities for both MyRAQA and our clients.
Friday, January 01, 2010
Growing more than 100% this year presents incredible opportunities for both MyRAQA and our clients.
Friday, January 01, 2010
IVDMIA: No Longer MIA?
I'm sure I'll have more to say when we see the final guidance.
Friday, December 04, 2009
I'm sure I'll have more to say when we see the final guidance.
Friday, December 04, 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
More Than One Best Way
There isn't a single way to design documentation or procedures.
Monday, November 23, 2009
There isn't a single way to design documentation or procedures.
Monday, November 23, 2009
Recent Reflections
Some important details that could help or hinder an application.
Monday, November 16, 2009
Some important details that could help or hinder an application.
Monday, November 16, 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
Happy Anniversary!
We've been working hard this past year to bring you great regulatory, quality and clinical support.
Tuesday, November 03, 2009
We've been working hard this past year to bring you great regulatory, quality and clinical support.
Tuesday, November 03, 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
No Exit Plan?
You may have to set the bar too high before you find out how high you can actually jump.
Friday, October 09, 2009
You may have to set the bar too high before you find out how high you can actually jump.
Friday, October 09, 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
Letter to an Aspiring RA Professional
Breaking into RA is all about that first job and what you do with it.
Monday, September 07, 2009
Breaking into RA is all about that first job and what you do with it.
Monday, September 07, 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
510(k)s Facing a "Hard Look"
You don't have to be part of the anti-regulation crowd to be concerned about narrowing the middle ground in this arena.
Thursday, June 18, 2009
You don't have to be part of the anti-regulation crowd to be concerned about narrowing the middle ground in this arena.
Thursday, June 18, 2009
CE Mark is Good, FDA Clearance is Great
Perhaps it is because of our regulation of the medical marketplace that it is such a valuable space to do business.
Monday, June 08, 2009
Perhaps it is because of our regulation of the medical marketplace that it is such a valuable space to do business.
Monday, June 08, 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
And the Award Goes To...
Not every regulatory process is a joy, but projects like this can serve to remind us why all of this is worthwhile.
Friday, May 22, 2009
Not every regulatory process is a joy, but projects like this can serve to remind us why all of this is worthwhile.
Friday, May 22, 2009
Careful with Claims
It can be frustrating to 'just know' your product can do more, but making claims that are not truly validated is simply unwise.
Monday, May 11, 2009
It can be frustrating to 'just know' your product can do more, but making claims that are not truly validated is simply unwise.
Monday, May 11, 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
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
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
A PMA Is Not the Kiss of Death
The amount of work you need to do for a PMA is not very much larger than the amount you are supposed to do for a 510(k).
Monday, April 27, 2009
The amount of work you need to do for a PMA is not very much larger than the amount you are supposed to do for a 510(k).
Monday, April 27, 2009
Know Your Audience
I have to hope that they might have thought twice about some of these choices if they had realized that FDA was attending the conference.
Wednesday, April 22, 2009
I have to hope that they might have thought twice about some of these choices if they had realized that FDA was attending the conference.
Wednesday, April 22, 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
Wrong results... again
How can we trust the fancy new molecular test for a particular drug if we can't even get the basics right?
Thursday, January 15, 2009
How can we trust the fancy new molecular test for a particular drug if we can't even get the basics right?
Thursday, January 15, 2009
Hope is Not a Good Plan
Partnerships can be a powerful asset to regulatory and marketing success.
Wednesday, January 14, 2009
Partnerships can be a powerful asset to regulatory and marketing success.
Wednesday, January 14, 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
Genentech Citizen's Petition
There is no public safety reason why the distribution method of diagnostic products should change their regulatory requirements.
Saturday, December 13, 2008
There is no public safety reason why the distribution method of diagnostic products should change their regulatory requirements.
Saturday, December 13, 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
IVDMIA: Any Day Now?
One thing I can say for sure: IVDMIA's passage would significantly change risk calculations for LDTs that qualify as mutivariate.
Monday, November 17, 2008
One thing I can say for sure: IVDMIA's passage would significantly change risk calculations for LDTs that qualify as mutivariate.
Monday, November 17, 2008
Creating Value in Difficult Times
How do you build value while you're cutting budgets?
Wednesday, November 12, 2008
How do you build value while you're cutting budgets?
Wednesday, November 12, 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
Stability Studies — Is accelerated data enough?
The time between testing points is a choice to be made for each product.
Wednesday, October 01, 2008
The time between testing points is a choice to be made for each product.
Wednesday, October 01, 2008
IVD MIA -- But the guidance is still draft...
At the moment FDA is giving assay developers a choice as to whether or not CLIA labs want to bring their multivariate assays to FDA for review.
Saturday, September 20, 2008
At the moment FDA is giving assay developers a choice as to whether or not CLIA labs want to bring their multivariate assays to FDA for review.
Saturday, September 20, 2008
Specimen Preparation Systems: Insider Info
What happens when you joke about starting a blog.
Friday, August 15, 2008
What happens when you joke about starting a blog.
Friday, August 15, 2008