Blog Posts with Tag: Industry

The Staple That Changed an Industry
LDT regulation and the perils of challenging Eminem to a rap battle
Tuesday, August 05, 2014
The Hero We All Needed
Lessons from boy that wanted to be Batman
Tuesday, November 19, 2013
FDA Only Half Closed For Business
Another gift from Congress that keeps on giving
Wednesday, October 09, 2013
The Call for Greater Transparency in Clinical Trials
Transparent isn't necessarily clear
Tuesday, September 10, 2013
Choosing Wisely
Can Informed Patients Help Improve Health Care Quality and Reduce Costs?
Tuesday, March 26, 2013
Taxing Compliance
The ambiguity of "device" takes on a whole new importance
Friday, December 07, 2012
Companion Diagnostics: LDTs Need Approval Too
The past is the past and tropism won't happen again
Tuesday, June 26, 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
Surpriseless in Silver Spring
Some thoughts on the CDRH/IOM Meeting
Friday, September 16, 2011
Policy Change We Can Believe In
Our RUO Guidance Comments
Tuesday, August 30, 2011
Promise and Peril in Diagnostics
Outgrowing good guys and bad guys
Tuesday, August 16, 2011
CU Bhind gym 2day 4real, LOL -FDA
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
The Big 510(k) Non-Announcement
It's more or less status quo for IVDs
Friday, January 21, 2011
The Incredible $24 Million 510(k)
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
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
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
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
The Wrong Raptor
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
The Trouble With Transparency
Sunlight may be the best disinfectant, but too much of it can cause melanoma.
Thursday, June 24, 2010
Getting DTC Genomics Right
Personal genomics must move beyond the phase of repackaging preliminary research as actionable information.
Friday, May 21, 2010

Recent Blogs

The Staple That Changed an Industry LDT regulation and the perils of challenging Eminem to a rap battle
FDA Releases the Kraken Whichever way this breaks, it's long past time to have this conversation in a meaningful way
Illumina Acquires Myraqa Acquisition Strengthens Illumina’s Clinical Readiness
The Spirit of GLP A Best Practice for IVDs
Process Performance Qualification (PPQ) Lots So, how many lots are required?
The Case for Risk-based Monitoring Better the devil you know...
Form Follows Function OIR Reorganizes to Meet the Advancing Wave of Molecular Diagnostics
CDRH Unveils New PMA Guidance Documents Attention shoppers, it's two-for-one day!