Waiting for LDT Guidance
What happens when Samuel Beckett, Tim Burton, and IVDs all meet at AMDM.
Tuesday, April 23, 2013
What happens when Samuel Beckett, Tim Burton, and IVDs all meet at AMDM.
Tuesday, April 23, 2013
The Pre-Submission Rosetta Stone
Translating FDA's Pre-Sub guidance into CoDx language
Friday, February 01, 2013
Translating FDA's Pre-Sub guidance into CoDx language
Friday, February 01, 2013
Once More Into the Breach Lads!
Is the time finally right for the CLIA lab to IVD business model?
Thursday, September 20, 2012
Is the time finally right for the CLIA lab to IVD business model?
Thursday, September 20, 2012
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FDA draft guidance on In Vitro Companion Diagnostics documents what we've been hearing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FDA draft guidance on In Vitro Companion Diagnostics documents what we've been hearing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
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
Lessons Learned in Project Management
Turns out even writing about project management can be a good lesson in the subject matter.
Tuesday, October 19, 2010
Turns out even writing about project management can be a good lesson in the subject matter.
Tuesday, October 19, 2010
Relationships Really Do Matter
How you manage your partners is one of the first things an auditor looks for
Tuesday, September 07, 2010
How you manage your partners is one of the first things an auditor looks for
Tuesday, September 07, 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 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
Bells, Whistles, and the Quest for Clinical Utility
Increasingly, FDA is becoming reluctant to clear tests that have a vague or general clinical utility.
Thursday, November 05, 2009
Increasingly, FDA is becoming reluctant to clear tests that have a vague or general clinical utility.
Thursday, November 05, 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
Enlightened Empowerment
The concept of giving people the power to do their job is sound, but it is frequently not well implemented.
Thursday, July 09, 2009
The concept of giving people the power to do their job is sound, but it is frequently not well implemented.
Thursday, July 09, 2009
Designed for (Future) Success
The consequences of a poorly developed IVD product go well beyond a few negative postings in a blog.
Wednesday, June 10, 2009
The consequences of a poorly developed IVD product go well beyond a few negative postings in a blog.
Wednesday, June 10, 2009
Turning Project Managers Into Project Leaders
A pack leader doesn't scream, get excited, or frustrated. They lead with what Cesar calls "calm, assertive energy."
Friday, April 03, 2009
A pack leader doesn't scream, get excited, or frustrated. They lead with what Cesar calls "calm, assertive energy."
Friday, April 03, 2009
What Do I Do With Project Management?
In an IVD firm, the project manager should be the de facto owner of the design control process.
Friday, March 20, 2009
In an IVD firm, the project manager should be the de facto owner of the design control process.
Friday, March 20, 2009