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
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
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
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
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FDA draft guidance on In Vitro Companion Diagnostics documents what we've been hearing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FDA draft guidance on In Vitro Companion Diagnostics documents what we've been hearing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
Does Anyone Have an Aspirin?
Review of the FDA public meeting on next-gen sequencing and diagnostics
Monday, June 27, 2011
Review of the FDA public meeting on next-gen sequencing and diagnostics
Monday, June 27, 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
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
We'll Drink to That
Enforcement discretion is ending. So let’s start with accepting the new reality, then get to work shaping it.
Friday, December 03, 2010
Enforcement discretion is ending. So let’s start with accepting the new reality, then get to work shaping it.
Friday, December 03, 2010
LDTs: Where's the Fire?
The news is not new about LDTs and their impending regulatory oversight.
Wednesday, December 01, 2010
The news is not new about LDTs and their impending regulatory oversight.
Wednesday, December 01, 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
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
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
Mind Your PQ's (and IQ's and OQ's)
These terms aren't defined in regulation, so what exactly do they mean?
Tuesday, October 05, 2010
These terms aren't defined in regulation, so what exactly do they mean?
Tuesday, October 05, 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
Hearing Global Harmonization
Getting a handle on national and regional requirements can be time-consuming
Tuesday, September 28, 2010
Getting a handle on national and regional requirements can be time-consuming
Tuesday, September 28, 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
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
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
The Wrong Raptor
Offering a successful LDT may be about the same amount of work as a full FDA submission.
Monday, July 12, 2010
Offering a successful LDT may be about the same amount of work as a full FDA submission.
Monday, July 12, 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
The Perils of Time Travel
Some questions you should ask (and FDA will ask) about your frozen clinical samples.
Tuesday, April 13, 2010
Some questions you should ask (and FDA will ask) about your frozen clinical samples.
Tuesday, April 13, 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
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
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
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
"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
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
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
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
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
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
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
Hologic HPV Approvals
This approval clearly demonstrates the FDA’s willingness to work with diagnostic companies on state-of-the-art molecular diagnostic testing.
Friday, April 10, 2009
This approval clearly demonstrates the FDA’s willingness to work with diagnostic companies on state-of-the-art molecular diagnostic testing.
Friday, April 10, 2009
IVD's and LDT's - What's the difference?
Molecular diagnostic tests have two compliant paths to the US market.
Wednesday, April 08, 2009
Molecular diagnostic tests have two compliant paths to the US market.
Wednesday, April 08, 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
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
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