Blog Posts with Tag: CoDx

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
CDRH Unveils New PMA Guidance Documents
Attention shoppers, it's two-for-one day!
Tuesday, April 29, 2014
No Substitute for Planning
Expecting a miracle isn't the best strategy
Monday, December 23, 2013
Breakthrough Therapies and CoDx
Proposals to help CoDx products keep up with Breakthrough Therapies
Tuesday, September 24, 2013
IDE Roulette
A little advice on when to file an IDE
Thursday, September 05, 2013
HER2/Neu Assay
The prototype for all companion diagnostic tests
Thursday, May 09, 2013
HIV Viral Load
The test that changed HIV treatment forever
Thursday, May 02, 2013
Biomarkers Are Not Magical
Let's be careful not to over-hype a good thing
Thursday, April 25, 2013
Life on the A-List
FDA seems to be sending mixed messages on LDTs and CoDx
Friday, March 22, 2013
Not Just Another Biomarker Meeting?
The IOM takes on co-development
Friday, March 01, 2013
Reviewing the Draft Guidance on IRB Responsibilities
It's so succinct it almost fits in a Tweet!
Wednesday, February 20, 2013
The Search for Shortcuts to Market
Companion Diagnostics and the Use of Enrichment Designs
Tuesday, February 05, 2013
The Pre-Submission Rosetta Stone
Translating FDA's Pre-Sub guidance into CoDx language
Friday, February 01, 2013
Change is Coming to CE-IVDD
The EU embraces its inner FDA
Tuesday, December 04, 2012
Once More Into the Breach Lads!
Is the time finally right for the CLIA lab to IVD business model?
Thursday, September 20, 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

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!