The Invisible Hand Pushes Back
A major payer proposes to restrict coverage of LDTs
Monday, October 17, 2011
A major payer proposes to restrict coverage of LDTs
Monday, October 17, 2011
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
Putting the "Lab" Back in LDTs
Clinical labs: FDA is not interested in shutting you down after the LDT meeting
Thursday, July 29, 2010
Clinical labs: FDA is not interested in shutting you down after the LDT meeting
Thursday, July 29, 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
Pathway's Looming World of Hurt
Thank your for your willingness to invite FDA enforcement in public.
Wednesday, May 12, 2010
Thank your for your willingness to invite FDA enforcement in public.
Wednesday, May 12, 2010
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
IVD's and LDT's - What's the difference?
Molecular diagnostic tests have two compliant paths to the US market.
Wednesday, April 08, 2009
Molecular diagnostic tests have two compliant paths to the US market.
Wednesday, April 08, 2009
Genentech Citizen's Petition
There is no public safety reason why the distribution method of diagnostic products should change their regulatory requirements.
Saturday, December 13, 2008
There is no public safety reason why the distribution method of diagnostic products should change their regulatory requirements.
Saturday, December 13, 2008
IVD MIA -- But the guidance is still draft...
At the moment FDA is giving assay developers a choice as to whether or not CLIA labs want to bring their multivariate assays to FDA for review.
Saturday, September 20, 2008
At the moment FDA is giving assay developers a choice as to whether or not CLIA labs want to bring their multivariate assays to FDA for review.
Saturday, September 20, 2008