Blog Posts with Tag: Policy

FDA Releases the Kraken
Whichever way this breaks, it's long past time to have this conversation in a meaningful way
Thursday, July 31, 2014
Form Follows Function
OIR Reorganizes to Meet the Advancing Wave of Molecular Diagnostics
Monday, May 05, 2014
A First Look at a New Review Paradigm
Working the bugs out of new methods for identifying bugs
Monday, April 14, 2014
FDA Announces New EUO Label
Draft guidance will lay out new path for devices
Tuesday, April 01, 2014
FDA Only Half Closed For Business
Another gift from Congress that keeps on giving
Wednesday, October 09, 2013
How Much Are Lab Tests Really Worth?
Charting a re-direction from a vicious to a virtuous cycle in test development
Wednesday, September 18, 2013
Our Point of Care Future
It's not just for chemistry tests any more
Monday, September 16, 2013
New Standards for Influenza Tests
FDA moving the bar up for performance
Friday, September 13, 2013
The Call for Greater Transparency in Clinical Trials
Transparent isn't necessarily clear
Tuesday, September 10, 2013
Everything That Rises Must Converge
the CMTP issues new guidance on how to identify cancer tests that work
Tuesday, August 06, 2013
The Sunshine Act Final Rule
Healthy Transparency, But Will It Change Anything?
Wednesday, July 03, 2013
Choosing Wisely
Can Informed Patients Help Improve Health Care Quality and Reduce Costs?
Tuesday, March 26, 2013
Paper is (Mostly) Dead
How I learned to stop worrying and love eCopies
Thursday, January 10, 2013
Taxing Compliance
The ambiguity of "device" takes on a whole new importance
Friday, December 07, 2012
Return of the Crystal Ball
What does an Obama re-election portend for the next four years?
Wednesday, November 07, 2012
Welcoming Our New OIRA Overlords
Will necessity and harmonization trigger a regulatory race to the bottom?
Monday, June 18, 2012
Waiting for Guidance
When will it be time for a final decision on LDTs?
Monday, June 11, 2012
Surpriseless in Silver Spring
Some thoughts on the CDRH/IOM Meeting
Friday, September 16, 2011
Promise and Peril in Diagnostics
Outgrowing good guys and bad guys
Tuesday, August 16, 2011
Fixing / Demolishing the 510(k)
The changes IOM proposes are both radical and entirely sensible
Monday, August 01, 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
Moving Beyond Fear
Charting a path through the new RUO landscape
Thursday, June 16, 2011
IVD Roundtable Meeting Recap
No knights, but plenty of great discussion nonetheless.
Monday, June 13, 2011
The Trouble With Transparency
Sunlight may be the best disinfectant, but too much of it can cause melanoma.
Thursday, June 24, 2010
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
The Right Balance
What are they actually asking for by urging a "risk-based" regulatory framework for IVDs and LDTs?
Friday, May 08, 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
"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

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!