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
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
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
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
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
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
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
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
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